5.1 DRUG PROFILE. Fig 5A Structure of Tenofovir. ({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2- yl]oxy}methyl)phosphonic acid

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2 5.1 DRUG PROFILE TENOFOVIR Tenofovir disoproxil fumarate ( TDF or PMPA [1] ) is an antiretroviral drug known as nucleotide analogue reverse transcriptase inhibitors (NRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIVinfected people. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV, and for the treatment of chronic hepatitis B. [2][3] Tenofovir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The most common side effects associated with tenofovir include nausea, vomiting, diarrhea, and asthenia. Less frequent side effects include hepatotoxicity, abdominal pain, and flatulence. [4] Tenofovir has also been implicated in causing renal toxicity, particularly at elevated concentrations. [5] Tenofovir can cause acute renal failure, Fanconi syndrome, proteinuria or tubular necrosis. These side effects are due to accumulation of the drug in proximal tubules. Tenofovir can interact with didanosine by increasing didanosine's concentration. It also decreases the concentration of atazanavir sulfate. Fig 5A Structure of Tenofovir IUPAC Name Formula Molecular weight Routes of Administration ({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2- yl]oxy}methyl)phosphonic acid C 9 H 14 N 5 O 4 P g/mol Oral 86 P a g e

3 Mechanism of action: Tenofovir inhibits the activity of HIV reverse transcriptase by competing with the natural substrate deoxyadenosine 5 - triphosphate and, after incorporation into DNA, by DNA chain termination. Specifically, the drugs are analogues of the naturally occurring deoxynucleotides needed to synthesize the viral DNA and they compete with the natural deoxy-nucleotides for incorporation into the growing viral DNA chain. However, unlike the natural deoxynucleotides substrates, NRTIs and NtRTIs (nucleoside/tide reverse transcriptase inhibitors) lack a 3'-hydroxyl group on the deoxy-ribose moiety. As a result, following incorporation of an NRTI or an NtRTI, the next incoming deoxy-nucleotide cannot form the next 5'-3' phosphor-diester bond needed to extend the DNA chain. Thus, when an NRTI or NtRTI is incorporated, viral DNA synthesis is halted, a process known as chain termination. All NRTIs and NtRTIs are classified as competitive substrate inhibitor Physicochemical properties: Tenofovir disoproxil fumarate (a prodrug of tenofovir) which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. Tenofovir disoproxil fumarate is a white to offwhite crystalline powder with a solubility of 13.4 mg/ml in distilled water at 25 C. It has an octanol/phosphate buffer (ph 6.5) partition coefficient (log p) of 1.25 at 25 C and pka is It is slightly soluble in water, soluble in methanol, very slightly soluble in dichloromethane. Clinical Indications: Tenofovir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. It is also indicated for the treatment of chronic hepatitis B in adults. Tenofovir is a nucleotide reverse transcriptase inhibitor used in combination with other antiretroviral, fort the treatment of HIV infection. It is acyclic phosphate nucleotide analogue; given by mouth. 87 P a g e

4 Table 5.1 List of brand names of Tenofovir S.No BRAND FORMULATION AVAILABLE NAME STRENGTH MANUFATURER 1 TAVIN Tablet 300 mg Emcure 2 TENOF Tablet 300 mg Hetero 3 TENTIDE Tablet 300 mg Ranbaxy 4 VONAVIR Tablet 300 mg Emcure 5 Tenvir Tablet 300mg Cipla 5.2 LITERATURE SURVEY Several analytical methods have reported for the determination of Tenofovir in pure drug, pharmaceutical dosage forms and in biological samples using Spectrophotometers, Liquid Chromatography, Electrokinetic Chromato-graphy, High Performance Thin Layer Chromatography and Mass Spectrometry either in single or in combined forms. N. Appala Raju et al [6] have been developed a simultaneous stability indicating RP-HPLC method for the estimation of Emtricitabine, Tenofovir disoproxil fumerate and Efavirenz in tablet dosage form. Chromatography was carried on an Inertsil ODS 3V column using gradient composition of 0.02M sodium dihydrogen orthophosphaste as mobile phase A and mixture of Methanol and water in ratio of 85:15 as mobile phase B at a flow rate of 1.5 ml/min with detection at 265 nm. The retention times of the Emtricitabine, Tenofovir disoproxil fumerate and Efavirenz was about 5.875, and mins respectively. The detector response is linear from 8-120μg/ml, μg/ml, and μg/ml of test concentration for Emtricitabine, Tenofovir and Efavirenz respectively. The respective linear regression equation being Y=10175x for Emtricitabine, Y=6280.8x for Tenofovir disoproxil fumerate and Y=1883.5x for Efavirenz. The limit of detection and Limit of quantification was 0.06, 0.07 and 0.08 μg/ml and 0.14, 0.12 and 0.15μg/ml for Emtricitabine, Tenofovir and Efavirenz respectively. The percentage assay of Emtricitabine, Tenofovir disoproxil fumerate and 88 P a g e

5 Efavirenz was 99.31, and % respectively and percentage recovery for average of three different concentrations was %, % and 99.52% respectively. The method was validated by determining its sensitivity, Linearity, accuracy and precision. The proposed method is simple, fast, sensitive, Linear, accurate, rugged and precise and hence can be applied for routine quality control of Emtricitabine, Tenofovir disoproxil fumerate and Efavirenz in bulk and in tablet dosage form. Rajesh Sharmal et al [7] have developed a rapid reversed-phase high performance liquid chromatographic method for estimation of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form. The estimation was carried out on Luna C18 (25cm x 4.60 mm, particle size 5μm) column with a mixture of acetonitrile: potassium dihydrogen phosphate buffer (ph 3.0 ± 0.05 adjusted with orthophosphoric acid): triethylamine in the ratio of 70:30:0.5(v/v) as mobile phase. UV detection was performed at 260 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time was 1.78 and 2.27 min. for emtricitabine and tenofovir disoproxil fumarate respectively and total run time was 4 min. at a flow rate of 1.5 ml min-1. The calibration curve was linear over the concentration range of 5-50 μg ml-1 for emtricitabine and 5-50 μg ml-1 for tenofovir disoproxil fumarate. The LOD and LOQ values were found to be and μg ml-1 for emtricitabine and and μg ml-1 for tenofovir disoproxil fumarate respectively. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form. Ananda kumar karunakaran et al [8] have developed and validated a simple, rapid reverse - phase high performance liquid chromatographic method for the simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in pure and in tablet dosage form. The estimation was carried out on a Phenomenax Luna C18 (150 mm x 4.6 mm i.d., particle size 5µm) column with a mixture of acetonitrile: methanol: water in the ratio of 30:50:20 (v/v) as 89 P a g e

6 mobile phase. UV detection was performed at 258 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time was 2.77 and 3.49 min. for emtricitabine and tenofovir disoproxil fumarate, respectively. The flow rate was 0.6 ml/ min. The calibration curve was linear over the concentration range of 2 12 µg ml-1 for emtricitabine and 1-6 µg/ ml for tenofovir disoproxil fumarate. The LOD and LOQ values were found to be and mg/ ml for emtricitabine and and mg/ ml for tenofovir disoproxil fumarate, respectively. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in pure and in tablet dosage for determination. Malipatil et al [9], have developed and validated a RP-HPLC method for determination of Tenofovir disoproxil fumarate (TDF) in bulk and pharmaceutical formulation. The chromatographic separation was achieved by using column Luna C18(2) ( mm, 5μl), containing mobile phase 0.1 % formic acid and Acetonitrile in ratio 50:50 was employed in this study. The flow rate was kept at 0.8 ml/min and the injection volume was 10μL. The retention time of TDF was min. Linearity of the method was good over the concentration range of 5-30μg/mL, and the correlation coefficient was found to be The separation was performed at an ambient temperature. Eluents were monitored by UV detector at 305 nm. The method was validated according to ICH guidelines. There was no significant difference in the intraday and interday, analysis of TDF determined for six different concentrations using this method. The RSD value % indicates a high precision of the analytical method. The proposed method was simple, sensitive, precise, accurate and useful for routine quality control analysis Motivation of the method development: The primary purpose of this research project was to develop and to validate a simple, precise and accurate HPLC method for determination of Tenofovir in the raw material and finished product. Tenofovir is the first orally-administered drug approved in the United 90 P a g e

7 States for the treatment of HIV infection. A high speed method was sought to measure the concentration of this compound within a short span of time. This is beneficial in any pharmaceutical analysis/clinical environment where the concentration of Tenofovir is needed to understand any patient issues along with the Pharmaceutical industry to prepare the multiple steps that may be needed to prepare the raw material for production. The high speed method will eliminate/reduce any waste or costs that are required with the preparation of the raw material. There are few analytical methods that have been reported for the determination of Tenofovir in Bulk and Formulations at the time of commencement of research work. Most of the reported methods have some setbacks and disadvantages of one or the other. These methods report mainly on the determination of Tenofovir in plasma and in blood samples. Such methods may not be suitable for regular/routine analysis for Tenofovir in pharmaceutical industry because of diversity and complexity in sample matrix. In addition, stability-indicating methods and related substances estimation have been able to be found for the Tenofovir in fixed dosage forms along with other anti retroviral drugs. Such simultaneous estimations are not adopted for single component analysis due to expensive factors and also long analytical procerdures. But the present proposed and developed method was more sensitive in that aspect with low flow rate to estimate the Tenofovir in pharmaceutical dosage forms in isocratic mode. Complete validation parameters were not to be found in any of the methods completed in the past. Studying the stability of a drug and being able to monitor degradation products aids in the clinical treatments/early product development and shelf life for the drug. One spectrophotometric method has reported for the estimation of Tenofovir in tablet dosage form by using Ferric Chloride and 2,2 Bipyridyl as chromogenic reagent. Analytical methods based on UV-Visible spectrophotometry have major disadvantage that they are time consuming & cumbersome and laborious. At the same time such methods require more quantity of Active pharmaceutical ingredients-i.e,-they are not much sensitive at microgram level. Also they are not suitable for regular/routine analysis in pharmaceutical industry where sample size is more. 91 P a g e

8 Hence, by considering all these factors, the author has made some humble attempts, hoping to fill this gap, and succeeded in developing analytical methods using HPLC methods. 5.3 EXPERIMENTAL Instrumentation PEAK HPLC containing LC 20AT pump and variable wavelength programmable LC-UV 7000 detector and Rheodyne injector was employed for investigation. The chromatographic analysis was performed on a kromasil C18 column (250 mm 4.6 mm, 7.5µm). Degassing of the mobile phase was done using a Loba ultrasonic bath sonicator. A Denwar Analytical balance was used for weighing the materials Chemicals and Solvents The reference sample of Tenofovir (API) was obtained from Sun Pharma, Baroda. The formulation Tavin (Ten ofovir) was purchased from the local market. Acetonitrile, Methanol, water used were of HPLC grade and purchased from Merck Specialties Private Limited, Mumbai, India The Mobile phase: The contents of the mobile phase were water: Acetonitrile: methanol in the ratio of 30:40:30 (v/v). They were filtered before use through a 0.45 μm membrane filter and degassed by sonication Standard solution of the drug A standard stock solution of the drug was prepared by dissolving 10 mg of Tenofovir USP in 10 ml volumetric flask containing 5 ml of methanol, sonicated for about 15 min and then made up to 10 ml with mobile phase to get approximately 1000 µg/ml. The primary standard solution was further diluted by taking 1 ml of the stock solution with 9 ml of mobile phase to get the concentration of 100µg/mL Sample (tablet) solution Twenty tablets of (Tavin mg) were weighed, and then powdered. A sample of the powdered tablets, equivalent to 92 P a g e

9 10mg of the active ingredient, was mixed with diluent in 10 ml volumetric flask. The mixture was allowed to stand for 1 hr with intermittent sonication for complete solubility of the drug, and then filtered through a 0.45 μm membrane filter, followed by addition of diluent up 10 ml to obtain a stock solution of 1000 µg/ml. The resultant solution was further diluted by taking 1 ml and diluted up to 10ml in 10ml volumetric flask with mobile phase as diluent to get the 100 mcg/ml and then filtered through Ultipor membrane sample filter paper (0.45µ filter) Calculations in Validation Studies Percentage recovery and area ration were calculated using the following equation: % recovery = ([Peak Area] sample / [Peak Area] Standard) x 100 For a set of n replicate measurements, percentage relative standard diviation was calculated as fallow: % RSD=SD/Average x 100 The detector sensitivity was determined by calculating the signal to noise ratio using the following equation: Sensitivity = S/N = Signal / Noise Signal = Amount of detector response to the peak from the middle of the noise to the summit of the peak. Noise = Amount of noise resulting from the detector that is taken from a portion of the baseline without any distortions. 5.4 METHOD DEVELOPMENT Method development: The goal of this research was to develop a reversedphase HPLC method that can be used to determine the active pharmaceutical ingredient in Tenofovir raw material with an adequate resolution and in a minimum analysis time. To begin method development, important structural information such as chemical structure, molecular weight, UV spectrum and sample solubility of the tenofovir was reviewed. The first step in method development was to survey the research journal articles to see if there was any previous work on method development reported. Method development consists of selecting the appropriate chromatographic conditions/ factors like detection wave length, selection and optimization of 93 P a g e

10 stationary and mobile phases. Systematic studies on various conditions / factors have been done for developing a method by studying each parameter by keeping all other parameters in constant. The following studies were conducted for this purpose Detection Wavelength: The proper wavelength was needed to determine maximum detector response. The first step was to run a UV-VIS spectrum (from nm) using an HPLC system equipped with the Photo Diode Array Detector, from the spectrum it is clear that Tenofovir absorbs maximum light between 240nm to 260 nm. The longer wavelength of 255 nm was selected since it produces less noise, which minimizes problems that may exhibit around the active ingredient when attempting to quantify Tenofovir. The spectra of diluted solutions of the Tenofovir in mobile phase (at 10 ppm concentration) were recorded separately on UV spectrophotometer. The spectra of Tenofovir, from both the concentrations showed absorption maximum at 255 nm. Also, the solvents in mobile phase/ diluents was shows no interference at the same wavelength and hence it is selected as detection wavelength Selection of Stationary Phase: An aged HPLC column should be used to develop the initial HPLC conditions. Usually it is more difficult to achieve the required resolution with an aged column (e.g., column with about 200 injections). This will reflect the worst case scenario likely to be encountered in actual method uses, and help the long-term method robustness. The preferred brand of HPLC column should be selected primarily based on the long term stability and lot-to-lot reproducibility. Preliminary development trials have performed with various octadecyl columns (C18 columns) of different types and dimensions from different manufacturers were tested for the peak shape and the number of theoretical plates of Tenofovir raw material at 500 µg/ml concentration. Finally by switching to Kromasil ODS-C18-3V column (250 mm x 4.6 mm, 5μ) column there was a substantial increase in the theoretical plates (~50000) with a significant improvement in the peak shapes with 1.14 tailing factor. It also produced adequate resolution for Tenofovir. As a result, it was selected as an optimum one and used throughout this investigation. 94 P a g e

11 5.4.3 Selection of the Mobile Phase: The solubility of Tenofovir was studied in order to determine t the proper ratio of solvents used as mobile phase to the drug substance for analysis. Referring to chemical structure, the compound is a base and is able to accept proton (s), therefore polarity of the dissolved solvent will affect the solubility. Different ratios of water and acetonitrile were tested with 2 minutes vortexing. To begin, 50 mg of Tenofovir reference standard was placed in a 50 ml volumetric flask. When pure water was tested, Tenofovir did not appear to dissolve completely and results in cloudy solution. On the other hand, when 100% acetonitrile was used, the compound dissolved instantly. To optimize the chromatographic conditions, different combinations of methanol water (90:10, 80:20, 70:30, 60:40, 50:50, 40:60, 30:70), acetonitrile water (90:10, 80:20, 70:30, 60:40, 50:50, 40:60, 30:70), and acetonitrile sodium dihydrogen phosphate buffer (90:10, 80:20, 70:30, 60:40, 50:50, 40:60, 30:70) were tested. Acetonitrile with phosphate buffer (ph 3.5) was preferred because it resulted in a greater response to Tenofovir after several preliminary investigatory runs compared with the other mobile phases. The composition, ph, and flow rate of the mobile phase were changed to optimize the separation conditions. Increasing the organic modifier content resulted in a decrease in the retention time (RT) of the drug. Furthermore, when a ratio of 50:50 water / acetonitrile was used, the compound did dissolve with some solid particles still persisted. Lastly, Tenofovir is dissolved completely in the proposed mobile phase of Water: Acetonitrile: Methanol: 30:40:30 % v/v/v without any turbidity and suspended particles. The ternary mixture was proved to be the appropriate among all combinations, with a better defined and well resolved peak, free from tailing. In order to get sharp peak and base line separation of the components, a number of experiments were carried out by varying the ph of solvents in mobile phase and its flow rate. The ph of the mobile phase will greatly affect its retention time as it interacts with the stationary phase. To start off, the ph of the mobile phase, which consisted of mono basic potassium dihydrogen phosphate, was adjusted to 3.2 with o-phosphoric acid. The reason for starting with low ph is to protonate all free silanol groups in the stationary phase and reduce their 95 P a g e

12 chromatographic activities. In theory, this should avoid any secondary interactions and also reduce tailing. Changing the buffer ph from 3.5 to 5.5 (by addition of sodium dihydrogen phosphate (0.01 M) or ortho-phosphoric acid) resulted in acceptable retention time and shape of the Tenofovir major peak. The effect of ph on analyte elution was related to the degree of ionization. Reducing the ph resulted in a shorter RT because of ionization of its basic site. A ph of 5.5 was regarded as optimum because at this ph the analyte peak was sharp and well-defined. Finally a mixture of Water: Acetonitrile: Methanol: 30:40:30 % v/v was at ph-5.5 adjusted with 10% o-phosphoric acid in water is proved to be the best suitable mobile phase among all the tested combinations. The chromatographic peaks obtained were better defined and resolved and almost free from tailing Flow Rate A minimum flow rate and minimum run time results the less usage of solvents. Flow rate of the mobile phase was tested from ml/min for optimum separation and it was found that 1.0 ml/min flow rate was ideal for the successful elution of the analyte Optimized chromatographic conditions Chromatographic conditions as optimized above were shown in Table 5.2. These optimized conditions were followed for the determination of Tenofovir in bulk samples and in its Formulations. No peak was observed when injected the blank solution which contain only mobile phase without drug. The chromatograms of standard, blank, tablet sample were shown in Figure 5.B, 5.C, 5.D respectively. Table 5.2: Optimized chromatographic conditions for estimation of Tenofovir Mobile phase Water: Acetonitrile :Methanol: 30:40:30 % v/v Pump mode Isocratic Mobile phase ph 5.5 Diluent Mobile phase Column kromasil C18 column (250 mm x 4.6 mm, 55μm Column Temp Ambient Wavelength 255 nm Injection Volume 20 μl 96 P a g e

13 Flow rate 1.0 ml/min Run time 8 min Retention Time min Figure 5B Chromatogram of standard solution Figure 5C Chromatogram of blank (No Peak) 97 P a g e

14 Figure: 5D Chromatogram of formulation 5.5 VALIDATION OF THE PROPOSED METHOD The proposed method was validated [10-19] as per ICH [10] guidelines. The parameters studied under validation were specificity, linearity, precision, accuracy, robustness, system suitability, limit of detection, limit of quantification, and solution stability Specificity The specificity of method was performed by comparing the chromatograms of blank, standard and sample (Prepared from Formulation). Each tablet contains 300 mg of Tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pre-gelatinized starch. The tablets are coated with Opadry II Y A, which contains FD&C blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin. It was found that there is no interference due to excipients in the tablet 98 P a g e

15 formulation and also found good correlation between the retention times of standard and sample. The specificity results are shown in Table 5.3 Table 5.3 Specificity study Name of the solution Retention Time in Min Blank No peak Standard Sample Linearity and Range Linearity is the ability of the method to elicit test results that are directly proportional to analyte concentration within a given range. Range is the interval between the upper and lower levels of analyte that have been demonstrated to be determined with precision, accuracy and linearity using the method as written. The ICH guidelines specify a minimum specified range is from % of the target concentration. Linearity was performed by preparing standard solutions of Tenofovir at different concentrations 3, 6, 9, 12, 15, 18 ppm. The peak responses were read at 255 nm and the corresponding chromatograms were recorded. From these chromatograms, the mean peak areas were calculated and linearity plots of concentration over the mean peak areas were constructed individually. The regressions of the plots were computed by least square regression method. Linearity results were presented in Table 5.4 Table 5.4 Linearity studies of Tenofovir Level Concentration of Tenofovir(µg/mL) Mean peak area Level Level Level Level Level Level Range: 3ppm to 18ppm Slope Intercept Correlation coefficient P a g e

16 Fig. 5E Calibration plot for Tenofovir Method Precision: Precision of the assay method was determined by repeatability (intra -day) and intermediate precision (inter -day) using the triplicate analysis of the Working Standard solutions. Repeatability shows the applicability of the analytical procedure within a laboratory over a short period of time that is evaluated by assaying the Working Standard solutions during the same day. Intermediate precision is assessed by comparing the assays on different days. Precision is the degree of repeatability of an analytical method under normal operational conditions. Precision of the method was performed as Intraday precision and Inter day precision Intraday precision To study the intraday precision, six replicate standard solutions (15ppm) of Tenofovir were prepared and injected using the proposed method. The percent relative standard deviation (% RSD) was calculated for the peak areas and it was found to be 0.3 %, which is well within the acceptance criteria of not more than 2.0%. Results of system precision studies are shown in Table 5.5. Table 5.5 Intraday Precision Results for Tenofovir Conc. RSD (Acceptance Sample Injection No. Peak Areas (in ppm) criteria 2.0%) Tenofovir P a g e

17 Inter Day precision To study the Inter day precision, six replicates of standard solutions (15ppm) of Tenofovir were injected on third day of sample preparation. The percent relative standard deviation (% RSD) was calculated and it was found to be 0.26 %, which is well within the acceptance criteria of not more than 2.0%. Results of Inter day system precision studies were shown in Table 5.6 Table 5.6 Inter Day Precision Results for Tenofovir Conc. Injection Peak RSD(Acceptance Sample (in ppm) No. Areas Criteria 2.0%) Tenofovir Accuracy: The accuracy of the developed method was tested to determine closeness of the measured value to the true value. Accuracy of the developed method was studied by evaluating the recovery of Tenofovir from spiked solutions. The accuracy of the method was determined by standard addition method. A known amount of standard drug was added to the fixed amount of pre-analyzed tablet solution. Percent recovery was calculated by comparing the area before and after the addition of the standard drug. The standard addition method was performed at 50%, 100% and 150% level of 12ppm. The solutions were analyzed in triplicate at each level as per the proposed method. The percent recovery was calculated and results are presented in Table 5.7. Satisfactory recoveries ranging from were obtained by the proposed method. This indicates that the proposed method was accurate. Table 5.7 Accuracy Results Amount of Tenofovir Level Spiked (µg/ml) Recovered((µg/mL) % Recovery 101 P a g e

18 50 % 6ppm % 12ppm % 18ppm Robustness: To ensure the insensitivity of the HPLC method to minor changes in the experimental conditions it is important to demonstrate robustness of the method. The robustness study was performed by slight modification optimized chromatographic conditions. The robustness study was performed by slight modification in mobile phase flow rate, ph and its composition. Tenofovir at 12 ppm concentration was analyzed under these changed experimental conditions. Three replicate injections were performed with each of the altered chromatographic condition and the mean peak area was compared against the mean peak area obtained with the unaltered conditions. It was observed that there were no marked changes in chromatography and the %assay when compared with unaltered conditions was within ± 2%, demonstrating that the developed method was robust in nature. The results of robustness study are shown in Table 5.8 Table 5.8 Robustness of Tenofovir Condition Mean area % assay % difference Unaltered wavelength at 253 nm Water :Acetonitrile Methanol35:40:25 ph of mobile phase at Solution Stability To perform the Stability test, three replicates of standard and sample solutions at 12ppm (stability samples) were prepared and stored separately at ambient temperature (20±10 C) for two days. After the intended storage period, both the standard and sample stability solutions were compared against a freshly prepared standard solution (comparison sample) using the proposed method. It is noticed that the % stability of Tenofovir was more than 98%, demonstrating insignificant degradation in both standard and formulation samples. The results of stability test were shown in Table P a g e

19 S. No Concentration (ppm) System suitability Table 5.9 Stability Results for Tenofovir Solution Fresh standard Solution (Comparison sample) Stored Standard Solution (Stability sample) Stored Sample Solution (Stability sample) Mean Peak Area % Stability System suitability was studied under each validation parameter by injecting six replicates of the standard solutions at 12ppm concentration. For the method following limits were considered as acceptance criteria, Tailing factor 2, Theoretical plates > 2000 and %RSD for peak area 2%. The results of system suitability tests were provided in table Table 5.10 System Suitability Results for Tenofovir Parameter Tailing factor Theoretical plates % RSD for peak response Specificity study Linearity study Precision study Limit of detection and Limit of quantification To determine the Limit of Detection (LOD) sample was dissolved by using Mobile phase and injected until peak was disappeared. After 0.025ppm dilution, Peak was not clearly observed. So it confirms that 0.025ppm is Limit of Detection and Limit of Quantification is 0.075ppm. For establishing LOQ, six replicates of standard at 0.075ppm were prepared and quantified with a relative standard deviation of %. The LOD and LOQ of Tenofovir are given in Table 5.11 Table 5.11 Limit of Detection and Limit of Quantification for Tenofovir Parameter Limit of Quantification Limit of Detection Measured volume 0.075ppm 0.025ppm 103 P a g e

20 5.5.9 Analysis of the Commercial Formulation Weigh 20 Tenofovir tablets (TAVIN-300mg) and calculate the average weight. Accurately weighed and transfer the sample equivalent to 10mg of Tenofovir in to a 10ml volumetric flask. Add diluents and sonicate to dissolve it completely and make volume up to the mark with diluents. Mix well and filter through 0.45um filter. Further pipette 1ml of the above stock solution into a 10ml volumetric flask and dilute up to mark with diluents and finally. Mix well and filter through 0.45um filter. An aliquot of this solution was injected into HPLC system. Peak area of Tenofovir was measured for the determination 5.6 Discussion on the Results Having optimized the efficiency of a chromatographic separation the quality of the chromatography was monitored by applying the following system suitability tests: capacity factor, tailing factor and theoretical plates. The system suitability method acceptance criteria set in each validation run were: capacity factor >2.0, tailing factor 2.0 and theoretical plates >2000. In all cases, the relative standard deviation (R.S.D) for the analytic peak area for two consecutive injections was < 2.0%. A chromatogram obtained from reference substance solution with the proposed method is suitable to get symmetric peak and System suitability values within the acceptance criteria. System suitability parameters were shown in Table: 5.10 Standard curves were constructed using six standard concentrations in a range of 3, 6, 9, 12, 15, 18 ppm for Tenofovir. The linearity of peak area responses versus concentrations was demonstrated by linear least square regression analysis. The linear regression equation was y = x (r= 0.998). Linearity values were shown in Table 5.4. Method precision was demonstrated by the assay of a series of six samples (15ppm), prepared as described above on two consecutive days. The inter- (RSD -0.26) and intra-(rsd-0.3)day means and relative standard deviation (R.S.D.) were calculated (Table: 5.5, 5.6). The assay method precision acceptance criteria set in the validation were a R.S.D. 2.0% for each data. The data of Precision meet these acceptance criteria. 104 P a g e

21 The accuracy of the method was evaluated by determination of the recovery of Tenofovir at three levels concentration. Tablets and capsules sample solutions were spiked with Tenofovir standard solution, corresponding to 50 to 150% of the nominal analytical concentration (12ppm). The res ults showed good recoveries ranging from 98.0 to %. The mean recovery data obtained for each level as well as for all levels combined (Table: 5.7) were within 2.0% of the label claim for the active substance with an R.S.D. < 2.0%, which satisfied the acceptance criteria set for the study. The sample was dissolved by using Mobile Phase and injected until peak was diapered. After 0.025ppm dilution Peak was not clearly observed. So it confirms that 0.025ppm limit of Detection. And Limit of Quantification is 0.075ppm. Typical variations in liquid chromatography conditions were used to evaluate the robustness of the assay method. In this study, the chromatographic parameters monitored were retention time, area, capacity factor, tailing factor and theoretical plates. The robustness acceptance criteria set in the validation were the same established on system suitability test describe above. The stability studies of Tenofovir was evaluated by comparing the results of freshly prepared standard solutions (12ppm ) and the standard solutions after two successive days of storage at ambient temperature (20 ± 10 0 C).In each case, it is noticed that solutions were stable for 48 hrs, as during this time the results did not decrease below 98%. This denotes that Tenofovir is stable and standard and sample solutions for at least 2 days at ambient temperature. The validated method was applied for the assay of commercial tablets Tavin- 300mg containing Tenofovir. Sample was analyzed for five times after extracting the drug as mentioned in assay sample preparation of the experimental section. The results presented good agreement with the labeled content. The proposed method for the assay of Tenofovir in tablets or capsules is very simple and rapid. It should be emphasized it is isocratic and the mobile phase do not contain any buffer. The method was validated for specificity, linearity, precision, accuracy and robustness. Although the method could effectively 105 P a g e

22 separate the drug from its degradation products, further studies should be performed in order to use it to evaluate the stability of pharmaceutical formulations. 106 P a g e

IJPAR Vol.3 Issue 4 Oct-Dec-2014 Journal Home page:

IJPAR Vol.3 Issue 4 Oct-Dec-2014 Journal Home page: IJPAR Vol.3 Issue 4 Oct-Dec-2014 Journal Home page: ISSN: 2320-2831 Research article Open Access Method development and validation of tenofovir disoproxil fumerate and emtricitabine in combined tablet

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