STABILITY INDICATING ASSAY. differentiate an intact drug from its potential decomposition products 425.
|
|
- Jeffry McCoy
- 5 years ago
- Views:
Transcription
1 .1. INTRODUCTION.1.1 STABILITY INDICATING ASSAY The stability - indicating assay is a method that is employed for the analysis of stability samples in pharmaceutical industry. It is essential to validate an assay with regards to its precision, accuracy, reproducibility, selectivity and robustness. In pharmaceutical research, in addition to these requirements, an assay is often required to be proven beyond doubt to be stability - indicating. A stability indicating assay is one that can accurately and selectively differentiate an intact drug from its potential decomposition products 425. The United States Food and Drug Administration draft guidelines of 1998 define stability indicating assays as validated quantitative analytical methods that can detect the changes with time in the chemical, physical or microbiological properties of the drug substance and drug product and that are specific so that the contents of active ingredient, degradation products and other components of interest can be accurately measured without interference. Thus according to definition, the discriminating nature of the method indicates the method to be stability indicating as well as stability - specific. The ICH guidelines require establishment of stability-indicating assays by conducting forced degradation studies or stress testing under a variety of conditions like ph, light, oxidation, dry heat etc. and separation of drug from degradation products. It is important to note that the necessity for stability - indicating capability applies to the complete testing regimen used for a given material and may not be necessary or appropriate for specific individual methods 426. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 305
2 Need for performing stability indicating assays 426 To differentiate the active ingredient from closely related impurities and degradation products. To provide assurance on detection of changes in identity, quantity and potency of the drug substance or drug product. To monitor the stability of a given drug in a finished product. To establish and confirm the shelf life of drug substances and drug products. To perform various other applications like cleaning, validation testing, performance testing i.e. dissolution testing Regulatory status of stability indicating assays The current guidelines available for stability testing of drug substances and products requires the conduct of stress testing or forced degradation studies for performing stability indicating assays but none of the guidelines specify how these studies emphasize that the testing of those features which are susceptible to change during storage and are likely to influence quality; safety and/or efficacy must be done by validated stability indicating testing methods (ICH guidelines Q1A on Stability Testing of New Drug Substances and Products) 427.The ICH guidelines Q1B on Photostability Testing of New Drug Substances and products mentions that the intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrated that an appropriate light exposure does not result in inappropriate change. The ICH guidelines Q6A on note for guidelines on specifications and Q5C on Stability Testing of Biotechnological/Biological Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 306
3 products also mention the requirement of stability-indicating assays 428. The requirements are also listed in the following- United States Food and Drug Administration stability guidelines and draft guidelines. World Health organization {WHO}. European Committee for Proprietary medicinal products. Canadian Therapeutic products Directorate s guidelines on stability testing. United States Pharmacopoeia {USP}. Current ICH guidelines Q7A on Good Manufacturing practices for Active Pharmaceutical Ingredients. Code of Federal Regulation{21CFR} Design of Stability Studies 429 A minimum of four samples should be generated for every stress condition, 1. The blank solution stored under normal conditions. 2. The blank subjected to stress in the same manner as the drug solution. 3. Zero time sample containing the drug which is stored under normal conditions. 4. Drug solution subjected to stress treatment. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 307
4 The comparison of the results of these provides real assessment of changes. It is advised to withdraw the samples at different time periods for each reaction condition. The information obtained from this is essential in establishment of Stability indicating analytical methods. Stability indicating analytical methods well established for active pharmaceutical ingredient and thus the allopathic medicine can be tested for it quality standards with respect to the degradation of the products. But the picture is not same with the plant based formulations. The basic standardization of the herbal products with the bioactive content is not well employed and the stability indicating methods are far away from the list of testing methods of their routine analysis. The fact remains the same that how much an allopathic medicine needs the stringent analytical protocol, the same is required for the plant based formulations. Thus, considering the need for development of stability indicating analytical methods for herbal medicine the objective of this study is as follows: To apply the developed and validated HPTLC method (as described in chapter 9, 10) for biomarkers namely; for the detection of forced degradation products of Conessine, Rutin and Quercetin. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 308
5 .2 STABILITY STUDIES OF RUTIN.2.1 Chromatographic conditions used for the developed and validated HPTLC method for rutin (Chapter 10) The following densitometric conditions were used for HPTLC studies: Stationary phase : : Precoated plates of Silica Gel 60 GF 254 (Merck) Mobile phase : Chloroform: methanol: formic acid (8.2:1.5:1) Saturation time Development time Wavelength Lamp Band width Length of : 15 min :15 min : 254 nm : Deuterium : 7 mm : 8 cm chromatogram Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 309
6 .2.2 Forced degradation studies of Rutin Acid degradation 1 M of hydrochloric acid (HCl) was prepared by diluting 8.5 ml of concentrated HCl to 100ml of distilled water. 1mg/ml solutions were prepared of rutin. 1 ml of rutin solution and 4 ml of 1N HCl were mixed and mixture was refluxed on water bath for 3 hours at 60 C. The refluxed solution of rutin and HCl was allowed to attend ambient temperature and then the refluxed solution was neutralized by 1 N NaOH to ph 7 and the volume was made up to 10 ml with methanol. Then the final solution was applied on to the TLC plates. Total degradation was found when the rutin was refluxed 1 N HCl for 3 hr, therefore the exposure time was reduced to 1 hr with the same concentration of HCl. Then the stressed sample was analyzed. The chromatogram of 1 hr refluxed sample showed the same pattern of degradation as that of 3 hr refluxed sample. There were total six peaks including peak of rutin at R f 0.19 and other peaks were detected at R f 0., 0.17, 0.34, 0.36, 0.49 (Fig..1). Thus, exposure time of the rutin to HCl was kept for 1 hr and the concentration of HCl was decreased to 0.1N. Further on analysis the stressed sample when analyzed showed almost no change as compared to the pervious conditions. Hence it was concluded that the rutin was not stable under any stressed acidic conditions tested. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 310
7 Fig..1: HPTLC Chromatogram of rutin after acid degradation Base degradation 1M of NaOH was prepared by dissolving 4 g of sodium hydroxide pellets in 100 ml of distilled water. 1 ml of rutin solution (1 mg/ml) and 4 ml of 1N NaOH were mixed and the mixture was refluxed on water bath for 3 hours at 60 C. The solution was allowed to attend ambient temperature then the solution was neutralized by 1 N HCl to ph 7 and the volume was made up to 10 ml with methanol. Then the final solution was applied on to the TLC plates. Total degradation was found when the rutin was refluxed 1 N NaOH for 3 hr, therefore the exposure time was reduced to 1 hr with the same concentration of NaOH. Then the stressed sample was analyzed. The chromatogram of 1 hr refluxed sample showed the same pattern of degradation as that of 3 hr Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 3
8 refluxed sample. There were total six peaks including peak of rutin at R f 0.22 were detected and other peaks at R f 0.09, 0.14, 0.23, 0.35, 0.54 (Fig..2). Thus, exposure time of the rutin to NaOH was kept for 1 hr and the concentration of NaOH was decreased to 0.1N. Further on analysis the stressed sample when analyzed showed almost no change as compared to the pervious conditions. Hence it was concluded that the rutin was not stable under any stressed alkaline conditions tested. Fig..2: HPTLC Chromatogram of rutin after base degradation Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 312
9 Oxidative degradation Oxidative degradation of rutin was studied using 3% of H 2 O 2 for 3 hr. 1 ml of rutin solution (1 mg/ml) and 9 ml 3 % H 2 O 2 solution were mixed and the mixture was refluxed on water bath for 3 hr at 60 C.The solution was allowed to attend ambient temperature and applied on to the TLC plates. When the sample was analyzed, three additional peaks were obtained of degradants. There were no additional peaks at same R f when untreated sample of rutin was analyzed confirming the formation of three degradation products (Fig..3). Comparison of the peak area of rutin in stressed condition with that of untreated sample revealed a 35.66% decrease. The UV spectra confirmed the peak of rutin in the stressed sample (Fig..4) Fig..3: HPTLC Chromatogram of rutin after oxidative stress Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 313
10 Degradant (254 nm, 366 nm) Rutin (standard) (254 nm, 366 nm Fig..4: UV spectrum of rutin (standard) and degraded product after oxidative stress Wet degradation 10 ml of aqueous rutin solution (1 mg/ml) were refluxed on water bath for 3 hr at 60 C. The solution was allowed to attend ambient temperature and applied on to the TLC plates. There were four peaks of degradants beside the rutin peak with the R f values 0.06, 0.36, 0.61, 0.80(Fig..5). Rutin peak at R f 0.21 was confirmed by comparing the UV spectrum with the untreated standard rutin. The λ max of the tested rutin (365) and even of the standard rutin λ max was 365 nm (Fig..6). Thus it was confirmed that only 22.76% of rutin was degraded. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 314
11 Fig..5: HPTLC Chromatogram of rutin after wet degradation Degradant (254 nm, 366 nm) Rutin (standard) (254 nm, 366 nm Fig.6: UV spectrum of rutin (standard) and degradation product after wet degradation Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 315
12 Dry heat 5mg of rutin was placed in oven for 3 hr at 100 C and then the heated sample of rutin was dissolved in 5ml of methanol. 5mg of rutin was placed in oven for 24 hr at 60 C and then the heated sample was dissolved in 5ml of methanol. The solution was allowed to attend ambient temperature and applied on to the TLC plates. When the stressed sample was analyzed, no degradation was found at both the conditions. Hence the exposure time was increased up to 48 hr and the temperature was kept constant at 60 C. When the stressed sample was analyzed, there were no additional peaks. The comparison between the peaks areas of stressed sample of rutin with that of untreated sample showed no difference (Fig..7). Hence it was concluded that drug was stable under the tested conditions. Fig..7: HPTLC Chromatogram of rutin after dry degradation Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 316
13 Photo stability study 5mg of rutin was exposed to UV short (254 nm) light for 24 hr. Then the exposed sample of rutin was dissolved in 5ml of methanol and applied on to the TLC plates. The stress study under short UV showed two additional peaks with R f 0.12, 0.64 (Fig..8). There were no additional peaks at the same R f of standard when the untreated sample was analyzed confirming the formation of two degradation products. Comparison of the peak area of rutin in stressed condition with that of untreated sample revealed % decrease in peak area of rutin under short UV. The UV spectra of the peak with R f 0.12 in stressed sample matched with the untreated rutin (Fig..9) and confirmed the presence of rutin. Thus it was concluded that 18.47% of rutin was degraded upon UV exposure. Fig..8: HPTLC Chromatogram of rutin after UV exposure Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 317
14 Rutin (standard) (254 nm, 366 nm) Degradant (254 nm, 366 nm) Fig..9: UV spectrum of rutin (standard) and degradation product after UV exposure Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 318
15 .3 STABILITY STUDIES OF QUERCETIN.3.1 Chromatographic conditions used for the developed and validated HPTLC method for quercetin (Chapter 10) The following densitometric conditions were used for HPTLC studies: Stationary phase : : Precoated plates of Silica Gel 60 GF 254 (Merck) Mobile phase : Chloroform: methanol: formic acid (8.2:1.5:1) Saturation time Development time Wavelength Lamp Band width Length of : 15 min :15 min : 254 nm : Deuterium : 7 mm : 8 cm chromatogram Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 319
16 .3.2 Forced degradation of Quercetin Acid degradation The hydrochloric acid (HCl) was prepared by diluting 8.5 ml of concentrated HCl to 100ml of distilled water. 1mg/ml solution was prepared of quercetin. 1 ml of quercetin solution and 4 ml of 1N HCl were mixed and the mixture was refluxed on water bath for 3 hours at 60 C. The refluxed solution of quercetin and HCl was allowed to attend ambient temperature and then the refluxed solution was neutralized by 1 N NaOH to ph 7 and the volume was made up to 10 ml with methanol. Then the final solution was applied on to the TLC plates. Total degradation was found when the quercetin was refluxed 1 N HCl for 3 hr, therefore the exposure time was reduced to 1 hr with the same concentration of HCl. Then the stressed sample was analyzed. The chromatogram of 1 hr refluxed sample showed the same pattern of degradation as that of 3 hr refluxed sample. There were six peaks which were degradants as none of the peak showed similar R f as that of standard. Among the all degradants peak at R f 0.29 was in highest percent (64.99%) (Fig..10) as compare to other degradation compounds. Thus, exposure time of the quercetin to HCl was kept for 1 hr and the concentration of HCl was decreased to 0.1N. Further on analysis the stressed sample when analyzed showed almost no change as compared to the pervious conditions. Hence it was concluded that the quercetin was not stable under any stressed acidic conditions tested. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 320
17 Fig..10: HPTLC Chromatogram of Quercetin after acid degradation Base degradation 1M of NaOH was prepared by dissolving 4 g of sodium hydroxide pellets in 100 ml of distilled water. 1 ml of quercetin solution (1 mg/ml) and 4 ml of 1N NaOH were mixed and refluxed on water bath for 3 hours at 60 C. The solution was allowed to attend ambient temperature and then the solution was neutralized by 1 N HCl to ph 7 and the volume was made up to 10 ml with methanol. Then the final solution was applied on to the TLC plates. Total degradation was found when the quercetin was refluxed 1 N NaOH for 3 hr, therefore the exposure time was reduced to 1 hr with the same concentration of NaOH. Then the stressed sample was analyzed. The chromatogram of 1 hr refluxed sample showed the same pattern of degradation as that of 3 hr refluxed sample. Thus, exposure time of the Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 321
18 quercetin to NaOH was kept for 1 hr and the concentration of NaOH was decreased to 0.1N. Further on analysis the stressed sample when analyzed showed, degradants peak at R f 0.22, 0.41, 0.59, The peak at R f 0.22 was in higher concentration with 84.47% (Fig..). Hence it was concluded that the quercetin was not stable under any stressed alkaline conditions tested. Fig..: HPTLC Chromatogram of Quercetin after base degradation Oxidative degradation 1 ml of quercetin solution (1 mg/ml) and 9 ml 3 % H solution were mixed and the mixture was refluxed on water bath for 3 hr at 60 C.The solution was allowed to attend ambient temperature and applied on to the TLC plates. There was no oxidative degradation quercetin found when studied using 3% of H 2 O 2 for 3 hr. The exposure time to oxidative condition was increased gradually up to 8 hr. When the stressed sample was analyzed, there were no additional peaks. There was no difference in peak area of stressed sample and Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 322
19 untreated sample of quercetin. Thus, it indicates that there was no degradation due to oxidative stress (Fig..12). Hence it was concluded that quercetin was stable under the conditions tested. Fig..12: HPTLC Chromatogram of quercetin after oxidative stress Wet degradation 10 ml of aqueous quercetin solution (1 mg/ml) were refluxed on water bath for 3 hr at 60 C. The solution was allowed to attend ambient temperature and then applied on to the TLC plates. There were three peaks of degradants beside the quercetin peak with the R f values 0.34, 0.56, 0.59, 0.76 (Fig..13). The R f of quercetin was shifted from 0.76 to At R f 0.76 there was a degradant peak was observed with higher percentage of peak area (51.81%). Quercetin peak at R f 0.92 was confirmed by comparing the UV spectrum with the untreated standard Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 323
20 quercetin (Fig..14). The λ max of the tested quercetin and of the standard quercetin λ max was 254 nm and 385 nm. Thus it was confirmed that 86.15% of quercetin was degraded. Fig..13: HPTLC Chromatogram of quercetin after wet degradation Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 324
21 Degradant (254 nm, 385 nm) Quercetin (standard) (254 nm, 385 nm) Fig.14: UV spectrum of quercetin (standard) and degradant (UV exposed condition) Dry Heat Degradation 5mg of quercetin was placed in oven for 3 hr at 100 C and then the hated sample of quercetin was dissolved in 5ml of methanol. 5mg of quercetin was placed in oven for 24 hr at 60 C and then the heated sample was dissolved in 5ml of methanol. The both the solutions were allowed to attend ambient temperature and applied on to the TLC plates. When the stressed sample of 3 hr at 100 C was analyzed, no degradation was found (Fig..15). But the sample of 24 hr at 60 C showed total three peaks out which one with R f 0.77 was of quercetin which was confirmed by the UV spectrum (Fig..16). The other two were (with R f 0.88, 0.96) of degradants and the total percent of degradation of quercetin was found to be 5.22 % (Fig..17 ). Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 325
22 Fig..15: HPTLC Chromatogram of quercetin after dry degradation for 3 hr at 100 C Fig..16: HPTLC Chromatogram of quercetin after dry degradation for 24 hr at 60 C Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 326
23 Degradant (254 nm, 385 nm) Quercetin (standard) (254 nm, 385 nm) Fig..17: UV spectrum of quercetin (standard) and degradant (Dry degradation for 24 hr at 60 C ) Photostability study 5mg of quercetin was exposed to UV short (254 nm) light for 24 hr to study the UV degradation. Then the exposed sample of quercetin was dissolved in 5ml of methanol and applied on to the TLC plates. When the stressed sample was analyzed there was no degradation observed of the quercetin sample (Fig..18). The sample was again exposed for 48 hr. Further chromatographic studies showed no degradation. Hence, it was concluded that the quercetin sample was stable under tested conditions. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 327
24 Fig..18: HPTLC Chromatogram of quercetin after UV exposure Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 328
25 .4 STABILITY STUDIES OF CONESSINE.4.1 Chromatographic conditions used for the developed and validated HPTLC method for conessine (Chapter 9) The following densitometric conditions were used for HPTLC studies: Stationary phase : : Precoated plates of Silica Gel 60 GF 254 (Merck) Mobile phase : Toluene: ethyl acetate: diethylamine (2.5:6.5:1) Saturation time Development time Wavelength Lamp Band width Length of : 15 min :15 min : 247 nm : Deuterium : 7 mm : 8 cm chromatogram Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 329
26 .4.2 Forced degradation of Conessine Acid degradation 1 M of hydrochloric acid (HCl) was prepared by diluting 8.5 ml of concentrated HCl to 100ml of distilled water.1mg/ml solutions was prepared of standard conessine. 1 ml of conessine solution and 4 ml of 1N HCL were mixed and the mixture was refluxed on water bath for 3 hours at 60 C. The solution was allowed to attend ambient temperature then the solution was neutralized by 1 N NaOH to ph 7 and the volume was made up to 10 ml with methanol. The final solution was applied on to the TLC plates. Total degradation was found when the conessine was refluxed 1 N HCl for 3 hr, therefore the exposure time was reduced to 1 hr with the same concentration of HCl. Then the stressed sample was analyzed. The chromatogram of 1 hr refluxed sample showed the same pattern of degradation as that of 3 hr refluxed sample. Thus, exposure time of the conessine to HCl was kept for 1 hr and the concentration of HCl was decreased to 0.1N. Further the stressed sample when analyzed showed no change as compare to pervious conditions. There were four peaks which were degradants (Fig..19). Among the all degradants, peak at R f 0.19 was in highest percent (35.43%) as compare to other degradation compounds. R f value of none of the peaks matched with the R f of treated sample. Hence it was concluded that the conessine was not stable under any stressed acidic conditions tested. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 330
27 Fig..19: HPTLC Chromatogram of conessine after acid degradation Base degradation 1M of NaOH was prepared by dissolving 4 g of sodium hydroxide pellets in 100 ml of distilled water. 1 ml of conessine solution (1 mg/ml) and 4 ml of 1N NaOH were mixed and the mixture was refluxed on water bath for 3 hours at 60 C. The solution was allowed to attend ambient temperature then the solution was neutralized by 1N HCl to ph 7 and the volume was made up to 10 ml with methanol. The final solution was applied on to the TLC plates. Total degradation was found when the conessine was refluxed 1 N NaOH for 3 hr, therefore the exposure time was reduced to 1 hr with the same concentration of NaOH. Then the stressed sample was analyzed. The chromatogram of 1 hr refluxed sample showed the same pattern of degradation as that of 3 hr refluxed sample. The degradants showed peak at R f Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 331
28 , The peak at R f 0.09 was in higher concentration with % (Fig..20). Thus, exposure time of the conessine to NaOH was kept for 1 hr and the concentration of NaOH was decreased to 0.1N. Further on analysis the stressed sample when analyzed showed almost no change as compared to the pervious conditions. Hence it was concluded that the conessine was not stable under any stressed alkaline conditions tested. Fig..20: HPTLC Chromatogram of conessine after base degradation Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 332
29 Oxidative degradation 1 ml of conessine solution (1 mg/ml) and 9 ml 3 % H solution were mixed and the mixture was refluxed on water bath for 3 hr at 60 C.The solution was allowed to attend ambient temperature and applied on to the TLC plates. There was no oxidative degradation conessine found when studied using 3% of H 2 O 2 for 3 hr. The exposure time to oxidative condition was increased gradually up to 8 hr. When the stressed sample was analyzed, there were no additional peaks. Also the comparison between the peak areas of stressed sample of conessine with that of untreated sample showed no difference, indicating that there was no degradation (Fig..21). Hence it was concluded that conessine was stable under the conditions tested. Fig..21: HPTLC Chromatogram of conessine after oxidative stress Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 333
30 Wet degradation 10 ml of aqueous conessine solution (1 mg/ml) was refluxed on water bath for 3 hr at 60 C. The solution was allowed to attend ambient temperature and applied on to the TLC plates. There was no degradation found when conessine was refluxed with water for 3hr, so the exposure time to wet condition was increased gradually up to 8 hr. When the stressed sample was analyzed, there were no additional peaks. The comparison between the peak areas of stressed sample of conessine with that of untreated sample showed no difference, indicating that there was no degradation (Fig..22). Hence it was concluded that the drug was stable under the conditions tested. Fig..22: HPTLC Chromatogram of conessine after wet degradation Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 334
31 Dry heat 5mg of conessine was placed in oven for 3 hr at 100 C and then the heated sample was dissolved in 5ml of methanol. 5mg of standard was placed in oven for 24 hr at 60 C and then the heated sample was dissolved in 5ml of methanol. The both the solutions were allowed to attend ambient temperature and were applied on to the TLC plates. When the stressed sample of 3 hr was analyzed, no degradation was found (Fig..23). But the sample of 24 hr showed total two peaks (Fig..24) out which one with R f 0.81 was of conessine which was confirmed by the UV spectrum (Fig..25). The other one was with R f 0.92 of degradant and the total percent of degradation of conessine was found to be 8.52 %. Fig..23: HPTLC Chromatogram of conessine after dry degradation for 3 hr at 100 C Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 335
32 Fig.. 24: HPTLC Chromatogram of conessine after dry degradation for 24 hr at 60 C Degradant (247 nm) Conessine (standard) (247 nm) Fig..25: UV spectrum of conessine(standard) and degradant (dry degradation for 3 hr at 100 C) Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 336
33 Photostability study 5mg of conessine was exposed to UV short (254 nm) light for 24 hr. Then the exposed sample was dissolved in 5ml of methanol and applied on to the TLC plates. When the stressed sample was analyzed there was no degradation observed of the conessine sample. The sample was again exposed to the wavelength for 48 hr. Further chromatographic studies showed no degradation (Fig..26). Hence, it was concluded that the conessine sample was stable under tested conditions. Fig..26: HPTLC Chromatogram of conessine after UV exposure Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 337
34 .5 CONCLUSION The application of developed and validated HPTLC methods for rutin, quercetin and conessine as stability indicating methods was successfully employed. It was observed that rutin was totally stable only under dry condition but the others conditions had altered the concentration of rutin. Quercetin was stable under oxidative stress and UV exposure but the peak area was lowered with presence of degradants peaks in all other stress conditions. Dry, wet, oxidative and UV exposure stress conditions could not affect the conessine marker. But conessine had degraded in acidic and basic conditions. Rutin and quercetin are biomarkers with very good anti-oxidant and many other therapeutic activities. They are even present in many medicinal plants. Thus the stability indicating method can very well adapted for the evaluations of many different formulations containing these two biomarkers. On other hand conessine is very specific biomarker to species Holarrhena with well proven pharmacological activities. Thus even the stability indicating method of this marker is essential and beneficial to have a check on the stability of formulations containing conessine. Standardization of Some Plant-Based Formulations By Modern Analytical Techniques 338
Development and Validation of Stability Indicating HPTLC Method for Estimation of Seratrodast
ARC Journal of Pharmaceutical Sciences (AJPS) Volume 2, Issue 3, 2016, PP 15-20 ISSN 2455-1538 DOI: http://dx.doi.org/10.20431/2455-1538.0203004 www.arcjournals.org Development and Validation of Stability
More informationINTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE
INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE STABILITY STUDY FOR ARGEMONE MEXICANA SHIRISH S. PINGALE Department of Chemistry, Gramonnati Mandal s Arts, Com. and Sci. College, Narayangaon,
More information2 5.1 Roots of Withania somnifera Structure of Withanolide G 99. A- C 22 -O- β-d-glucoside) Structure of Withaferin A 100
LIST OF FIGURES 1 1.1 Standardization and Quality Evaluation of Herbal Drugs 33 2 5.1 Roots of Withania somnifera 97 3 5.2 Structure of Withanolide G 99 4 5.3 Structure of Sitoindosides IX (withaferin-a-c
More informationStability indicating thin-layer chromatographic determination of eslicarbazepine acetate as bulk drug: Application to forced degradation study
Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2016, 8 (11):38-47 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4
More informationCYCLOSERINI CAPSULAE - CYCLOSERINE CAPSULES (AUGUST 2015)
August 2015 Document for comment 1 2 3 4 5 CYCLOSERINI CAPSULAE - CYCLOSERINE CAPSULES DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA (AUGUST 2015) DRAFT FOR COMMENT 6 Should you have any comments
More informationTitle Revision n date
A. THIN LAYER CHROMATOGRAPHIC TECHNIQUE (TLC) 1. SCOPE The method describes the identification of hydrocortisone acetate, dexamethasone, betamethasone, betamethasone 17-valerate and triamcinolone acetonide
More informationJPSBR: Volume 4, Issue 6: 2014 ( ) ISSN NO
Analytical Method Development and Validation for Simultaneous Estimation of Timolol Maleate and Brimonidine in Bulk and Marketed Ophthalmic Formulation Suketa K. Mehta*, Dr. Dilip G. Maheshwari Department
More informationvii LIST OF TABLES TABLE NO DESCRIPTION PAGE 1.1 System Suitability Parameters and Recommendations Acidic and Alkaline Hydrolysis 15
vii LIST OF TABLES TABLE NO DESCRIPTION PAGE CHAPTER- 1 1.1 System Suitability Parameters and Recommendations 07 1.2 Acidic and Alkaline Hydrolysis 15 1.3 Oxidative Degradation Study 16 1.4 Hydrolysis
More informationPROPOSAL FOR REVISION OF MONOGRAPH PUBLISHED IN The International Pharmacopoeia: REVISION OF ph test ABACAVIR ORAL SOLUTION (JULY 2012)
July 2012 RESTRICTED PROPOSAL FOR REVISION OF MONOGRAPH PUBLISHED IN The International Pharmacopoeia: REVISION OF ph test ABACAVIR ORAL SOLUTION (JULY 2012) PROPOSED REVISION FOR COMMENT The background
More informationARTESUNATE TABLETS: Final text for revision of The International Pharmacopoeia (December 2009) ARTESUNATI COMPRESSI ARTESUNATE TABLETS
December 2009 ARTESUNATE TABLETS: Final text for revision of The International Pharmacopoeia (December 2009) This monograph was adopted at the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical
More informationDRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA: CARBAMAZEPINI COMPRESSI - CARBAMAZEPINE TABLETS
December 2015 Draft document for comment 1 2 3 4 5 6 DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA: CARBAMAZEPINI COMPRESSI - CARBAMAZEPINE TABLETS (December 2015) REVISED DRAFT FOR COMMENT Should
More informationTENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010)
June 2010 TENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010) This monograph was adopted at the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical
More informationHPTLC Determination of Atomoxetine Hydrochloride from its Bulk Drug and Pharmaceutical Preparations
Asian Journal of Chemistry Vol. 20, No. 7 (2008), 5409-5413 HPTLC Determination of Atomoxetine Hydrochloride from its Bulk Drug and Pharmaceutical Preparations S.S. KAMAT, VINAYAK T. VELE, VISHAL C. CHOUDHARI
More informationAnalytical method validation. Presented by Debbie Parker 4 July, 2016
Analytical method validation Presented by Debbie Parker 4 July, 2016 Introduction This session will cover: Guidance and references The types of test methods Validation requirements Summary Slide 2 PharmOut
More informationAbstract. G. D. Patil 1, P. G. Yeole 1, Manisha Puranik 1 and S. J. Wadher 1 *
International Journal of ChemTech Research ISSN : 0974-4290 Vol.1,No.1,pp 16-26, Jan March 2009 A Validated Specific Reverse Phase Liquid Chromatographic Method for the Determination of Valacyclovir in
More informationDepartment Of Quality Assurance Techniques, Modern College of Pharmacy Nigdi, Pune Maharashtra, India
IJPSR (2013), Vol. 4, Issue 1 (Research Article) Received on 20 September, 2012; received in revised form, 06 November, 2012; accepted, 22 December, 2012 DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING
More informationDhull Rohit, Kumar Sanjay, Jalwal Pawan Department of Chemistry, OPJS Churu, Rajasthan, India
International Journal of Advanced Science and Research ISSN: 2455-4227, Impact Factor: RJIF 5.12 www.allsciencejournal.com Volume 2; Issue 2; March 2017; Page No. 31-40 Validated gradient stability indicating
More informationDevelopment and Validation of HPTLC Method for Estimation of Tramadol HCl in Bulk and in Capsule Dosage Form
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.4, No.3, pp 1261-1265, July-Sept 2012 Development and Validation of HPTLC Method for Estimation of Tramadol HCl in Bulk
More informationCHAPTER INTRODUCTION OF DOSAGE FORM AND LITERATURE REVIEW
132 CHAPTER 6 DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF PARACETAMOL, TRAMADOL HYDROCHLORIDE AND DOMPERIDONE IN A COMBINED DOSAGE FORM 6.1 INTRODUCTION
More informationLEVONORGESTREL AND ETHINYLESTRADIOL TABLETS. (January 2012) DRAFT FOR COMMENT
January 2012 RESTRICTED DRAFT PROPOSAL FOR The International Pharmacopoeia LEVONORGESTREL AND ETHINYLESTRADIOL TABLETS (January 2012) DRAFT FOR COMMENT This document was provided by a quality control expert.
More informationDRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA PAEDIATRIC RETINOL ORAL SOLUTION (August 2010)
August 2010 RESTRICTED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA PAEDIATRIC RETINOL ORAL SOLUTION (August 2010) DRAFT FOR COMMENT This document was provided by a quality control expert and was
More informationA simple stability indicating high performance thin layer chromatography (HPTLC) method was developed and
ISSN: 0975766X CODEN: IJPTFI Available Online through Research Article www.ijptonline.com DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF IFENESIN
More informationSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS Draft proposal for The International Pharmacopoeia (September 2010)
September 2010 RESTRICTED SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS Draft proposal for The International Pharmacopoeia (September 2010) REVISED DRAFT FOR COMMENT This document was provided by a quality
More informationDraft monograph for inclusion in. The International Pharmacopoeia. Dextromethorphani solutionum peroralum - Dextromethorphan oral solution
August 2015 Draft document for comment 1 2 3 4 5 6 Draft monograph for inclusion in The International Pharmacopoeia Dextromethorphani solutionum peroralum - Dextromethorphan oral solution (August 2015)
More informationABACAVIR SULFATE Proposal for revision of The International Pharmacopoeia (August 2012)
August 2012 RESTRICTED ABACAVIR SULFATE Proposal for revision of The International Pharmacopoeia (August 2012) Draft for comment This document was provided by a quality control expert. Should you have
More informationINTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LAMIVUDINE TABLETS
RESTRICTED INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LAMIVUDINE TABLETS DRAFT FOR COMMENT Please address any comments you may have on this document, by 12 July 2006, to Dr S. Kopp, Quality Assurance and
More informationCONTENT. i iv ix. SVKM s NMIMS, School of Pharmacy and Technology Management
CONTENT Chapter No. Title Page No. Abbreviations List of Figures List of Tables 1 Introduction 1 1.1 Practical aspects 4 1.2 Stability-indicating assay method (SIAM) 5 1.3 Regulatory aspects 6 1.4 Techniques
More informationSimultaneous Estimation and Validation of Tramadol and Paracetamol by HPTLC in Pure and Pharmaceutical Dosage Form
Asian Journal of Chemistry Vol. 22, No. 2 (2010), 850-854 Simultaneous Estimation and Validation of Tramadol and Paracetamol by HPTLC in Pure and Pharmaceutical Dosage Form C. ROOSEWELT*, N. HARIHRISHNAN,
More informationINTRODUCTION. safety and efficacy throughout all phases of its shelf life, including storage. In
INTRODUCTION Analytically monitoring of a pharmaceutical product is necessary to ensure its safety and efficacy throughout all phases of its shelf life, including storage. In Simultaneous processing of
More informationDevelopment and Validation of Stability Indicating HPLC method for Determination of Eperisone HCL in Bulk and in Formulation
Development and Validation of Stability Indicating HPLC method for Determination of Eperisone HCL in Bulk and in Formulation Sanjay Patil 1, Suvarna Vanjari 2, Rajendra Patil 3, Tushar Deshmukh 4 1 TSSM
More informationRITONAVIRI COMPRESSI RITONAVIR TABLETS. Final text for addition to The International Pharmacopoeia (July 2012)
July 2012 RITONAVIRI COMPRESSI RITONAVIR TABLETS Final text for addition to The International Pharmacopoeia (July 2012) This monograph was adopted at the Forty-sixth WHO Expert Committee on Specifications
More informationREVISED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA RETINOL CONCENTRATE, OILY FORM. (August 2010)
August 2010 RESTRICTED REVISED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA RETINOL CONCENTRATE, OILY FORM (August 2010) DRAFT FOR COMMENT This document was provided by a quality control expert
More informationSUMMARY, CONCLUSION & RECOMMENDATIONS
196 Chapter-5 SUMMARY, CONCLUSION & RECOMMENDATIONS 197 CHAPTER 5 5.1 Summary, Conclusion and Recommendations Summary and Conclusion are drawn based on the work carried out by the author on development
More informationTHIN LAYER CHROMATOGRAPHY
THIN LAYER CHROMATOGRAPHY Thin layer chromatography is the best known technique of plant biochemistry. TLC is used for preliminary separation and determination of plant constituents. It is helpful for
More informationF. Al-Rimawi* Faculty of Science and Technology, Al-Quds University, P.O. Box 20002, East Jerusalem. Abstract
JJC Jordan Journal of Chemistry Vol. 4 No.4, 2009, pp. 357-365 Development and Validation of Analytical Method for Fluconazole and Fluconazole Related Compounds (A, B, and C) in Capsule Formulations by
More informationPelagia Research Library
Available online at www.pelagiaresearchlibrary.com Der Pharmacia Sinica, 2015, 6(4): 30-37 ISSN: 0976-8688 CODEN (USA): PSHIBD Development and validation of stability indicating RP-HPLC method for simultaneous
More informationVol-3, Issue-4, Suppl-1, Nov 2012 ISSN: Ghodasara et al PHARMA SCIENCE MONITOR
PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES HPTLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DIOSGENIN AND GALLIC ACID IN MARKETED FORMULATION Ghodasara
More informationDEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF ALOGLIPTIN BENZOATE IN BULK DRUGS AND TABLET DOSAGE FORMS
DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF ALOGLIPTIN BENZOATE IN BULK DRUGS AND TABLET DOSAGE FORMS KOMAL SHARMA *1 & AMRITA PARLE 2 ABSTRACT A new, simple, precise, accurate and selective
More informationInt. J. Pharm. Sci. Rev. Res., 30(1), January February 2015; Article No. 32, Pages:
Research Article Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Cilnidipine in Bulk and Pharmaceutical Dosage Form. Atul Kadam* 1, Dr. (Mrs.) Purnima Hamrapurkar
More informationAvailable online at Universal Research Publications. All rights reserved. Original Article
Available online at http://www.urpjournals.com International Journal of Analytical and Bioanalytical chemistry Universal Research Publications. All rights reserved Original Article Application of HPTLC
More informationDevelopment And Validation Of HPTLC Method For Simultaneous Estimation Of Rutin And Quercetin In Hydroalcoholic Extract Of Triphala Churna
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.4, No.4, pp 1457-1463, Oct-Dec 2012 Development And Validation Of HPTLC Method For Simultaneous Estimation Of Rutin
More informationResearch Article Derivative Spectrophotometric Method for Estimation of Metformin Hydrochloride in Bulk Drug and Dosage Form
Research Article Derivative Spectrophotometric Method for Estimation of Metformin Hydrochloride in Bulk Drug and Dosage Form Gowekar NM, Lawande YS*, Jadhav DP, Hase RS and Savita N. Gowekar Department
More informationJournal of Chemical and Pharmaceutical Research
Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(2):770-775 Validation of Rapid Liquid Chromatographic
More informationASSAY AND IMPURITY METHOD FOR DURACOR TABLETS BY HPLC
ASSAY AND IMPURITY METHOD FOR DURACOR TABLETS BY HPLC METHOD APPROVALS Norvin Pharma Inc. Author Analytical Laboratory Approver Analytical Laboratory Group Leader Approver Manager Quality Control Chemistry
More informationSimultaneous estimation of Metformin HCl and Sitagliptin in drug substance and drug products by RP-HPLC method
International Journal of Chemical and Pharmaceutical Sciences 2017, Mar., Vol. 8 (1) ISSN: 0976-9390 IJCPS Simultaneous estimation of Metformin HCl and Sitagliptin in drug substance and drug products by
More informationAccelerated Stability Studies on Valacyclovir Hydrochloride by RP-HPLC
Accelerated Stability Studies on Valacyclovir Hydrochloride by RP-HPLC Research Article VMK. Gowtham Potnuru, C. Jothimanivannan *, CH. Arjun, M. Jambulingam, S. Ananda Thangadurai and D. Kamalakannan
More informationTenofovir disoproxil fumarate (Tenofoviri disoproxili fumaras)
C 19 H 30 N 5 O 10 P. C 4 H 4 O 4 Relative molecular mass. 635.5. Chemical names. bis(1-methylethyl) 5-{[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl}-5-oxo-2,4,6,8-tetraoxa-5-λ 5 - phosphanonanedioate
More informationValidated UV Spectrophotometric Method Development And Stability Studies Of Acamprosate Calcium In Bulk And Tablet Dosage Form
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.5, No.3, pp 1241-1246, July-Sept 2013 Validated UV Spectrophotometric Method Development And Stability Studies Of Acamprosate
More informationRevision of monograph in the 4 th Edition of The International Pharmacopoeia (August 2008)
August 2008 RESTRICTED MEBENDAZOLE Revision of monograph in the 4 th Edition of The International Pharmacopoeia (August 2008) REVISED DRAFT FOR ADOPTION This document was provided by a quality control
More informationReceived: 29 Oct 2013, Revised and Accepted: 20 Oct 2013
Academic Sciences International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 6, Issue 1, 2013 Research Article STABILITY INDICATING ASSAY METHD FR QUANTIFICATIN F LACSAMIDE IN BULK
More informationEMTRICITABINE AND TENOFOVIR TABLETS
September 2010 RESTRICTED EMTRICITABINE AND TENOFOVIR TABLETS Draft proposal for The International Pharmacopoeia (September2010) REVISED DRAFT FOR COMMENT This document was provided by a quality control
More informationCYCLOSERINE Proposal for revision of The International Pharmacopoeia (August 2012)
August 2012 RESTRICTED CYCLOSERINE Proposal for revision of The International Pharmacopoeia (August 2012) Draft for comment This document was provided by a quality control expert. Should you have any comments
More informationDepartment of Pharmaceutical Analysis, KMCH College of Pharmacy, Coimbatore-35, India
World Journal of Pharmaceutical Sciences ISSN (Print): 2321-3310; ISSN (Online): 2321-3086 Published by Atom and Cell Publishers All Rights Reserved Available online at: http://www.wjpsonline.com/ Research
More informationScholars Research Library
Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2010, 2(5): 363-370 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4
More informationA New Stability-Indicating and Validated RP-HPLC Method for the Estimation of Liraglutide in Bulk and Pharmaceutical Dosage Forms
OPEN ACCESS Eurasian Journal of Analytical Chemistry ISSN: 1306-3057 2017 12(2):31-44 DOI 10.12973/ejac.2017.00152a A New Stability-Indicating and Validated RP-HPLC Method for the Estimation of Liraglutide
More informationA Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Valsartan and Clinidipine Combined Tablet dosage forms
World Journal of Pharmaceutical Sciences ISSN (Print): 2321-3310; ISSN (Online): 2321-3086 Published by Atom and Cell Publishers All Rights Reserved Available online at: http://www.wjpsonline.org/ Original
More information------------------------------------------------------------------------------------------------------------------------ HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR QUANTIFICATION OF PIPERINE
More informationAvailable Online through Research Article
ISSN: 0975-766X Available Online through Research Article www.ijptonline.com SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF FROVATRIPTAN SUCCINATE MONOHYDRATE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
More informationDraft proposal for The International Pharmacopoeia
April 2012 RESTRICTED SULFAMETHOXAZOLE AND TRIMETHOPRIM INTRAVENOUS INFUSION Draft proposal for The International Pharmacopoeia (April 2012) DRAFT FOR COMMENT This document was provided by a quality control
More informationDevelopment and Validation of a Simultaneous HPLC Method for Quantification of Amlodipine Besylate and Metoprolol Tartrate in Tablets
Journal of PharmaSciTech 0; ():- Research Article Development and Validation of a Simultaneous HPLC Method for Quantification of Amlodipine Besylate and Metoprolol Tartrate in Tablets * Sayyed Hussain,
More informationVol-3, Issue-4, Suppl-1, Nov 2012 ISSN: Shingala et al PHARMA SCIENCE MONITOR
PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF GALLIC ACID AND ANDROGRAPHOLIDE IN POLYHERBAL FORMULATION Dhara Shingala*,
More informationResearch Article Simultaneous Estimation of DL-Methionine and Pyridoxine Hydrochloride in Tablet Dosage Form by RP-HPLC
Research Article Simultaneous Estimation of DL-Methionine and Pyridoxine Hydrochloride in Tablet Dosage Form by RP-HPLC Shinde Prashanti 1 *, Mane Aruna 2, Palled Mahesh 1, Bhat AR 1 and Karagane Swapna
More informationDevelopment and Validation of HPTLC Method for Quantification of Silodosin in Bulk and Pharmaceutical Dosage Form
ISSN: 2277-7695 CODEN Code: PIHNBQ ZDB-Number: 2663038-2 IC Journal No: 7725 Vol. 1 No. 10 2012 Online Available at: THE PHARMA INNOVATION Development and Validation of HPTLC Method for Quantification
More informationComparative HPTLC Analysis of Leaves of Allium cepa L., Ficus carica L. and Ziziphus mauritiana L. with Standard Quercetin
Available online on www.ijppr.com International Journal of Pharmacognosy and Phytochemical Research 2017; 9(5); 739-743 DOI number: 10.25258/phyto.v9i2.8157 ISSN: 0975-4873 Research Article Comparative
More informationA HPTLC method for chemotaxonomic evaluation of some Curcuma Species and their commercial samples
Journal of Scientific & Industrial Research 876 Vol. 68, October 2009, pp. 876-880 J SCI IND RES VOL 68 OCTOBER 2009 A HPTLC method for chemotaxonomic evaluation of some Curcuma Species and their commercial
More informationStability Indicating Method Development and Validation for the Estimation of Rotigotine by RP-HPLC in Bulk and Pharmaceutical Dosage Form
ORIENTAL JOURNAL OF CHEMISTRY An International Open Free Access, Peer Reviewed Research Journal www.orientjchem.org ISSN: 0970-020 X CODEN: OJCHEG 2015, Vol. 31, No. (4): Pg. 2499-2505 Stability Indicating
More informationDRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA EFAVIRENZ, EMTRICITABINE AND TENOFOVIR TABLETS
September 2010 RESTRICTED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA EFAVIRENZ, EMTRICITABINE AND TENOFOVIR TABLETS (August 2010) DRAFT FOR COMMENT This document was provided by a quality control
More informationHYDROLYTIC DEGRADATION PROFILING OF EZETIMIBE BY HPLC METHOD
International Journal of Medicine and Pharmaceutical Science (IJMPS) ISSN(P): 2250-0049; ISSN(E): 2321-0095 Vol. 7, Issue 2, Apr 2017, 1-6 TJPRC Pvt. Ltd. HYDROLYTIC DEGRADATION PROFILING OF EZETIMIBE
More informationAvailable online at Scholars Research Library
Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2015, 7 (3):157-161 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4
More informationStability indicating RP-HPLC method development and validation of Etizolam and Propranolol hydrochloride in pharmaceutical dosage form
World Journal of Pharmaceutical Sciences ISSN (Print): 2321-3310; ISSN (Online): 2321-3086 Published by Atom and Cell Publishers All Rights Reserved Available online at: http://www.wjpsonline.org/ Original
More informationFormulation stability studies. 9.1 OBJECTIVE To monitor the stability of the developed herbal formulations using the limited and specific methods.
9.1 OBJECTIVE To monitor the stability of the developed herbal formulations using the limited and specific methods. 9.2 INTRODUCTION The legal definition of stability is aimed at assuring that the drug
More informationZIDOVUDINE, LAMIVUDINE AND ABACAVIR TABLETS Draft proposal for The International Pharmacopoeia (September 2006)
September 2006 RESTRICTED ZIDOVUDINE, LAMIVUDINE AND ABACAVIR TABLETS Draft proposal for The International Pharmacopoeia (September 2006) This document was provided by a contracted quality control laboratory.
More informationDevelopment and Validation of a RPLC Method for the Determination of 2-Phenoxyethanol in Senselle Lubricant Formulation
Research Paper Development and Validation of a RPLC Method for the Determination of 2-Phenoxyethanol in Senselle Lubricant Formulation G. A. SHABIR*, T. K. BRADSHAW, G. Q. SHAR 1 AND S. A. ARAIN 2 Oxford
More informationWorld Journal of Pharmaceutical Research
World Journal of Pharmaceutical ReseaRch Volume 3, Issue 3, 4527-4535. Research Article ISSN 2277 715 DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF RAMOSETRON Zarana
More information(ACE) inhibitor class that is primarily used in cardiovascular. conditions. Lisinopril was introduced into therapy in the early
107 CHAPTER 5 METHODDEVOLOPMENT FOR SIMULTANEOUS DETERMINATION OF LISINOPRIL AND HYDROCHLOROTHIAZIDE RELATED IMPURITIES IN LISINOPRIL AND HYDROCHLOROTHIAZIDE COMBINED TABLET DOSAGE FORMS USING HPLC 108
More informationDevelopment and validation for the simultaneous quantification of Montelukast and Levocetirizine by UV, RP-HPLC and HPTLC methods in tablets
IJPAR Vol.5 Issue 3 July - Sep -2016 Journal Home page: ISSN:2320-2831 Research article Open Access Development and validation for the simultaneous quantification of Montelukast and Levocetirizine by UV,
More informationCHAPTER 8 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) ANALYSIS OF PHYTOCHEMICAL CONSTITUENTS OF M. ROXBURGHIANUS AND P. FRATERNUS PLANT EXTRACTS
CHAPTER 8 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) ANALYSIS OF PHYTOCHEMICAL CONSTITUENTS OF M. ROXBURGHIANUS AND P. FRATERNUS PLANT EXTRACTS CHAPTER 8: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)
More informationAsian Journal of Pharmaceutical Analysis and Medicinal Chemistry Journal home page:
Research Article CODEN: AJPAD7 ISSN: 2321-0923 Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry Journal home page: www.ajpamc.com ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEFITINIB
More informationDEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF GLIMEPIRIDE AND METFORMIN HYDROCHLORIDE
IJPSR (2015), Vol. 6, Issue 3 (Research Article) Received on 21 July, 2014; received in revised form, 29 September, 2014; accepted, 01 December, 2014; published 01 March, 2015 DEVELOPMENT AND VALIDATION
More informationValidation of HPTLC Method for Quantification of Embelin from Embelia ribes Burm. F.
Available online on www.ijppr.com International Journal of Pharmacognosy and Phytochemical Research 2016; 8(9); 1492-1496 Research Article ISSN: 0975-4873 Validation of HPTLC Method for Quantification
More informationInternational Journal of Applied Pharmaceutical Sciences and Research
International Journal of Applied Pharmaceutical Sciences and Research 2017; 2(3): 55-63 Anas et al/international Journal of Applied Pharmaceutical Sciences and Research 2017; 2(3): 55-63 International
More informationIJRPC 2013, 3(2) Nagamallika et al. ISSN: INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY
INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY Available online at www.ijrpc.com Research Article A VALIDATED STABILITY INDICATING RP-UPLC METHOD FOR SIMULTANEOUS DETERMINATION OF WATER SOLUBLE
More informationAvailable online Research Article
Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2016, 8(1):171-176 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 Reverse phase high performance liquid chromatography
More informationRao and Gowrisankar: Stability-indicating RP-HPLC Method for Pseudoephedrine, Ambroxol and Desloratadine
Research Paper Development and Validation of Stability-indicating RP- HPLC Method for the Estimation of Pseudoephedrine, Ambroxol and Desloratadine in Bulk and Tablet Dosage Forms N. MALLIKARJUNA RAO*
More informationCHAPTER-6 IDENTIFICATION, AND CHARACTERISATION OF DEGRADATION IMPURITY IN VALSARTAN TABLETS
129 CHAPTER-6 IDENTIFICATION, AND CHARACTERISATION OF DEGRADATION IMPURITY IN VALSARTAN TABLETS 130 6.1. Introduction Valsartan is an orally active specific angiotensin II blocker effective in lowering
More informationDevelopment and Validation of Stability Indicating RP- HPLC Method for Simultaneous Estimation of Beclomethasone Dipropionate and Clotrimazole
OPEN ACCESS Eurasian Journal of Analytical Chemistry ISSN: 1306-3057 2017 12(4):395-404 DOI 10.12973/ejac.2017.00177a Development and Validation of Stability Indicating RP- HPLC Method for Simultaneous
More informationDevelopment and Validation of a New Uv Method for the Analysis of Rebamipide
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.3, No.3, pp1270-1274, July-Sept 2011 Development and Validation of a New Uv Method for the Analysis of Rebamipide Praveen
More informationHyderabad, India. Department of Pharmaceutical Chemistry, Glocal University, Saharanpur, India.
International Journal On Engineering Technology and Sciences IJETS RP-HPLC Method development and validation for the Simultaneous Estimation of Metformin and Empagliflozine in Tablet Dosage Form Shaik
More informationSmall Scale Preparative Isolation of Corticosteroid Degradation Products Using Mass-Based Fraction Collection Application
Small Scale Preparative Isolation of Corticosteroid Degradation Products Using Mass-Based Fraction Collection Application Pharmaceutical Author Cliff Woodward Agilent Technologies, Inc. 285 Centerville
More informationHPTLC Method for estimation of Gallic acid and Rutin in Haritaki -An Ayurvedic Formulation
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol. 3, No.2, pp 986-999, April-June 2011 HPTLC Method for estimation of Gallic acid and Rutin in Haritaki -An Ayurvedic
More informationThe Nitrofurantoin Capsules Revision Bulletin supersedes the currently official monograph.
Nitrofurantoin Capsules Type of Posting Revision Bulletin Posting Date 28 Dec 2018 Official Date 01 Jan 2019 Expert Committee Chemical Medicines Monographs 1 Reason for Revision Compliance In accordance
More informationARTENIMOLUM ARTENIMOL. Adopted revised text for addition to The International Pharmacopoeia
February 2012 ARTENIMOLUM ARTENIMOL Adopted revised text for addition to The International Pharmacopoeia This monograph was adopted at the Forty-sixth WHO Expert Committee on Specifications for Pharmaceutical
More informationSTABILITY INDICATING HPLC METHOD FOR DETERMINATION OF RIMONABANT
Int. J. Chem. Sci.: 9(2), 2011, 481-488 ISSN 0972-768X www.sadgurupublications.com STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF RIMONABANT Y. PADMAVATHI *, P. HARI KRISHNA and B. MADHAVA REDDY
More informationSimultaneous Determination of Cinchocaine Hydrochloride and Betamethasone Valerate in Presence of Their Degradation Products
Journal of Chromatographic Science, 2017, Vol. 55, No. 5, 518 527 doi: 10.1093/chromsci/bmx004 Advance Access Publication Date: 7 February 2017 Article Article Simultaneous Determination of Cinchocaine
More informationJournal of Chemical and Pharmaceutical Research, 2017, 9(9): Research Article
Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2017, 9(9):70-80 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 Development and Validation of Stability Indicating
More informationGB Translated English of Chinese Standard: GB NATIONAL STANDARD OF THE
Translated English of Chinese Standard: GB5009.85-2016 www.chinesestandard.net Buy True-PDF Auto-delivery. Sales@ChineseStandard.net GB NATIONAL STANDARD OF THE PEOPLE S REPUBLIC OF CHINA GB 5009.85-2016
More informationDEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF IVERMECTIN AND ALBENDAZOLE IN PHARMACEUTICAL DOSAGE FORM
Indian Journal of Drugs, 2015, 3(3), 57-70 ISSN: 2348-1684 DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF IVERMECTIN AND ALBENDAZOLE IN PHARMACEUTICAL DOSAGE FORM Patel
More informationUmapathi et al. Keywords: Fixed dose combination; Rifampin quinone; Tuberculosis; Sodium ascorbate; Quantitative determination; HPLC
Tropical Journal of Pharmaceutical Research December 2010; 9 (6): 587-593 Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria. All rights reserved. Available online
More informationDevelopment and validation of stability indicating RP-LC method for estimation of calcium dobesilate in pharmaceutical formulations
Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2016, 8 (11):236-242 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4
More informationMEDAK DIST. ANDHRA PRADESH STATE, INDIA. Research Article RECEIVED ON ACCEPTED ON
Page67 Available Online through IJPBS Volume 1 Issue 2 APRIL- JUNE 2011 SIMPLE QUANTITATIVE METHOD DEVELOPMENT AND VALIDATION OF VALSARTAN IN PUREFORM AND PHARMACEUTICAL DOSAGE FORMS BYUV SPECTROSCOPY
More information