Application Note Ginseng for Ginsenosides by HPLC. Botanical Name: Common Names:

Similar documents
Application Note. Treatment of poor memory, memory loss, Alzheimer s disease, peripheral vascular disease.

Application Note Soy for Isoflavones by HPLC. Botanical Name: Glycine max L. Common Names: Parts of Plant Used: Beans.

Application Note. Eye-balm, goldenseal, ground raspberry, wild turmeric, yellow eye, yellow paint, yellow root

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF LACOSAMIDE IN BULK AND ITS PHARMACEUTICAL FORMULATION

METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC FOR ESTIMATION OF ZOLPIDEM TARTARATE

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD ESTIMATION OF TOLVAPTAN IN BULK PHARMACEUTICAL FORMULATION

Optimization of Enzyme-assisted Ultrasonic Extraction of Total Ginsenosides from Ginseng Roots Guangna LIU, Yulin ZUO, Jing ZHANG

Title Revision n date

Development, Estimation and Validation of Lisinopril in Bulk and its Pharmaceutical Formulation by HPLC Method

Journal of Chemical and Pharmaceutical Research, 2017, 9(9): Research Article

ASSAY AND IMPURITY METHOD FOR DURACOR TABLETS BY HPLC

Development and validation of stability indicating RP-LC method for estimation of calcium dobesilate in pharmaceutical formulations

Application Note. Commiphora mukul; Balsamodendron mukul; Commiphora wightii. Treatment of hyperlipidemia, reduction of lipid and cholesterol levels

Application Note. Agilent Application Solution Analysis of ascorbic acid, citric acid and benzoic acid in orange juice. Author. Abstract.

RITONAVIRI COMPRESSI RITONAVIR TABLETS. Final text for addition to The International Pharmacopoeia (July 2012)

Simultaneous estimation of Metformin HCl and Sitagliptin in drug substance and drug products by RP-HPLC method

Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry Journal home page:

Analysis of Isoflavones with the PerkinElmer Flexar FX-15 UHPLC System Equipped with a PDA Detector

Pelagia Research Library

Novel, Universal Approach for the Measurement of Natural Products in a Variety of Botanicals and Supplements, Part 2

RP-HPLC Analysis of Temozolomide in Pharmaceutical Dosage Forms

Validated RP- HPLC Method for the Quantitative Estimation of Valsartan in Bulk and Pharmaceutical Dosage Forms

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS TOLBUTAMIDE IN PURE AND PHARMACEUTICAL FORMULATIONS

Journal of Chemical and Pharmaceutical Research, 2013, 5(1): Research Article

ARTESUNATE TABLETS: Final text for revision of The International Pharmacopoeia (December 2009) ARTESUNATI COMPRESSI ARTESUNATE TABLETS

Development and Validation for Simultaneous Estimation of Sitagliptin and Metformin in Pharmaceutical Dosage Form using RP-HPLC Method

Rebaudioside a From Multiple Gene Donors Expressed in Yarrowia Lipolytica

TENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010)

PAPRIKA EXTRACT SYNONYMS DEFINITION DESCRIPTION FUNCTIONAL USES CHARACTERISTICS

Journal of Pharmacreations

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

INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LAMIVUDINE TABLETS

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF TRAMADOL IN PURE AND PHARMACEUTICAL FORMULATIONS

Isocratic Reversed Phase Liquid Chromatographic Method Validation for the Determination of Cilostazol in Pure and Formulations

RP-HPLC Method Development and Validation of Abacavir Sulphate in Bulk and Tablet Dosage Form

Application Note. Agilent Application Solution Analysis of fat-soluble vitamins from food matrix for nutrition labeling. Abstract.

CHAPTER INTRODUCTION OF DOSAGE FORM AND LITERATURE REVIEW

SIMULTANEOUS ESTIMATION OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN TABLETS BY RP-HPLC METHOD

Analysis of Commercially Available Products Containing Stevia

World Journal of Pharmaceutical Research

Determination of Tetracyclines in Chicken by Solid-Phase Extraction and High-Performance Liquid Chromatography

Determination of Ginseng in Dietary Supplements and Dietary Ingredients. Stakeholder Panel on Dietary Supplements (SPDS)

CHAPTER INTRODUCTION OF DOSAGE FORM AND LITERATURE REVIEW

A New Stability-Indicating and Validated RP-HPLC Method for the Estimation of Liraglutide in Bulk and Pharmaceutical Dosage Forms

Journal of Chemical and Pharmaceutical Research, 2018, 10(3): Research Article

A Validated Rp-Hplc Method for the estimation of Milnacipran in Tablet dosage forms

Journal of Chemical and Pharmaceutical Research

Quetiapine Tablets. Expert Committee Monographs Chemical Medicines 4 Reason for Revision Compliance

Determination of β2-agonists in Pork Using Agilent SampliQ SCX Solid-Phase Extraction Cartridges and Liquid Chromatography-Tandem Mass Spectrometry

Analysis of Counterfeit Antidiabetic Drugs by UHPLC with the Agilent 1220 Infinity Mobile LC

Determination of 6-Chloropicolinic Acid (6-CPA) in Crops by Liquid Chromatography with Tandem Mass Spectrometry Detection. EPL-BAS Method No.

(ACE) inhibitor class that is primarily used in cardiovascular. conditions. Lisinopril was introduced into therapy in the early

Estimation of Zanamivir Drug present in Tablets using RP-HPLC Method

HPLC Analysis of Sugars

Tramadol Hydrochloride Extended-Release Tablets. Expert Committee Chemical Medicines Monographs 2 Reason for Revision Compliance

Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Haloperidol and Trihexyphenidyl in API and Combined Tablet Dosage Form

Analytical Method Development and Validation for the Estimation of Guaifenesin and Dextromethorphan by RP-HPLC

Analytical Method for 2, 4, 5-T (Targeted to Agricultural, Animal and Fishery Products)

Development and validation of related substances method for Varenicline and its impurities

Shuguang Li, Jason Anspach, Sky Countryman, and Erica Pike Phenomenex, Inc., 411 Madrid Ave., Torrance, CA USA PO _W

Lutein Esters from Tagetes Erecta

Analysis of HMF by HPLC

CHAPTER 2 SIMULTANEOUS DETRMINATION OF ANASTROZOLE AND TEMOZOLOMIDE TEMOZOLOMIDE CAPSULES 20 MG AND ANASTROZOLE TABLETS 1 MG

Hyderabad, India. Department of Pharmaceutical Chemistry, Glocal University, Saharanpur, India.

SUMMARY, CONCLUSION & RECOMMENDATIONS

A RAPID AND SENSITIVE ANALYSIS METHOD OF SUDAN RED I, II, III & IV IN TOMATO SAUCE USING ULTRA PERFORMANCE LC MS/MS

Comparison of conventional HPLC with UPLC method for determination of albuterol sulfate and it s impurities in pharmaceutical formulation

FLUNITRAZEPAM Latest Revision: January 24, 2006

Method Development and Validation for Simultaneous Estimation of Atorvastatin and Ezetimibe in Pharmaceutical Dosage Form by HPLC

Simultaneous Quantification of 13 Ginsenosides by LC-MS/MS and its Application in Diverse Ginseng Extracts

Journal of Chemical and Pharmaceutical Research

DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA: CARBAMAZEPINI COMPRESSI - CARBAMAZEPINE TABLETS

F. Al-Rimawi* Faculty of Science and Technology, Al-Quds University, P.O. Box 20002, East Jerusalem. Abstract

This revision also necessitates a change in the table numbering in the test for Organic Impurities.

DEVELOPMENT AND VALIDATION OF NEW HPLC METHOD FOR THE ESTIMATION OF PALIPERIDONE IN PHARMACEUTICAL DOSAGE FORMS

vii LIST OF TABLES TABLE NO DESCRIPTION PAGE 1.1 System Suitability Parameters and Recommendations Acidic and Alkaline Hydrolysis 15

Rapid and sensitive UHPLC screening of additives in carbonated beverages with a robust organic acid column

Jagua (Genipin-Glycine) Blue (Tentative)

New RP-HPLC Method for the Determination of Fludarabine in Pharmaceutical Dosage Forms

Relative Measurement of Zeaxanthin Stereoisomers by Chiral HPLC

A simple validated RP-HPLC method for quantification of sumatriptan succinate in bulk and pharmaceutical dosage form

A Reverse Phase HPLC Method Development and Validation for the Determination of Paliperidone in Pure and Dosage Forms

Development and validation of RP-HPLC method for simultaneous estimation of gliclazide and metformin in pure and tablet dosage form

Amphetamines, Phentermine, and Designer Stimulant Quantitation Using an Agilent 6430 LC/MS/MS

Extraction of Aflatoxin M1 From Infant Formula Using ISOLUTE Myco SPE Columns prior to LC-MS/MS Analysis

Int. J. Pharm. Sci. Rev. Res., 30(1), January February 2015; Article No. 32, Pages:

Abstract. G. D. Patil 1, P. G. Yeole 1, Manisha Puranik 1 and S. J. Wadher 1 *

Research Article DEVOLOPMENT OF RP-HPLC METHOD AND IT S VALIDATION FOR SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND METFORMIN

Steviol Glycosides from Stevia rebaudiana Bertoni

ANALYTICAL TECHNIQUES FOR THE QUALITY OF ANTI- AIDS DRUGS

Scholars Research Library

Microemulsion High Performance Liquid Chromatography (MELC) for Determination of Terbutaline in Urine Samples

Development and validation of liquid chromatographic method for trazodone hydrochloride

Analytical Method Development for USP Related Compounds in Paclitaxel Using an Agilent Poroshell 120 PFP

A stability indicating RP-HPLC method for simultaneous estimation of darunavir and cobicistat in bulk and tablet dosage form

Pelagia Research Library

Humco Compounding, 313 East 12th Street, Suite 230, Austin, TX 78701, USA; Tel.:

Development and Validation of Multiresidue Pesticide Methods at FDA/CFSAN

ZIDOVUDINE, LAMIVUDINE AND ABACAVIR TABLETS Draft proposal for The International Pharmacopoeia (September 2006)

Available online at Scholars Research Library

Transcription:

Application Note 0048 - Ginseng for Ginsenosides by PLC As published in The andbook of Analytical Methods for Dietary Supplements Botanical Name: Common Names: Panax ginseng; Panax quinquefolium American ginseng (Panax quinquefolium), Asian ginseng, Chinese ginseng (Panax ginseng), Korean ginseng NOTE: Eleutherococcus senticosus (Eleuthero) is often referred to as Siberian ginseng ; however, it is not related to Asian or American ginseng, and the following analytical methods do not apply to Eleuthero. Parts of Plant Used: Roots NOTE: Some ground ginseng powders or extracts may be adulterated with ginseng leaves. This type of adulteration usually can be detected by visual inspection: the material will have a green tint, as opposed to the typical reddish brown tint obtained from the roots. Uses: Both Asian and American ginsengs traditionally have been used as tonics to reduce effects of stress, to counteract fatigue, and to increase stamina. Modes of Action: There is very little clinical evidence that Asian and American ginsengs possess the pharmacological properties ascribed to them. Any activity that ginseng may have is generally attributed to a group of triterpenoid saponin glycosides commonly called ginsenosides. There are two main groups of ginsenosides, which are referred to as panaxadiols or panaxatriols, depending upon the number of hydroxyl groups attached to the saponin backbone. The ginsenosides are structurally related to sterols such as cholestanol. There is no known mode of action for the ginsenosides. Chemical Markers: Both Asian and American ginsengs are assayed for their ginsenoside content. More than 20 ginsenosides have been identified, but typically only seven are assayed: ginsenosides Rb1, Rb2, Rc, Rd, Re, Rf, and Rg1. The remaining ginsenosides are present in very low concentrations. While both Asian and American ginsengs contain these same ginsenosides, the individual ratios are different between the two species. The structures of the marker compounds follow. R 1 O R2 R 3 O O Ginsenoside R 1 R 2 R 3 Rb1 Glc 2 -Glc Glc 6 -Glc Rb2 Glc 2 -Glc Glc 6 -Ara(p) Rc Glc 2 -Glc Glc 6 -Ara(f) Rd Glc 2 -Glc Glc Re O-Glc 2 -Rha Glc Rf O-Glc 2 -Glc Rg1 O-Glc

2 0048 - Ginseng for Ginsenosides by PLC Methods of Analysis Most published analytical methods utilize reversed-phase PLC with gradient elution and low-wavelength UV detection. Ginsenosides are very water soluble, owing to the presence of the sugar-group moieties; therefore, mobile phases are generally highly aqueous. Because ginsenosides do not possess a good chromophore, low-wavelength UV detection (203 to 205 nm) usually is used to take advantage of the absorptivity of the alkene group. Acetonitrile must be used as the organic modifier in the mobile phase to enable detection at these low wavelengths. Other more exotic detection techniques that are not dependent upon chromophores, such as evaporative light-scattering detection or MS, can be used. Extraction of the ginsenosides from the matrix is of key importance. Ginsenosides have good solubility in aqueous extraction solvents, with decreasing solubility as the concentration of the organic modifier increases. Above about 40% organic concentration in the extraction solvent, incomplete recovery or inconsistent results occur, and multiple extractions must be performed on the sample. Acidic or basic extraction solvents also should be avoided, as hydrolysis of the glycosides can occur. Method 1: Court et al. 1 developed a gradient reversed-phase PLC method for the determination of not only the seven listed ginsenosides, but also ginsenosides Rg2, Ro, F11, and gypenoside XVII in ground ginseng. Extract about 300 mg of ground ginseng root with 10 ml of methanol water (70:30) in an ultrasonication bath for 15 minutes. Remove the solvent, and repeat the extraction of the residue twice. Dry the combined extracts under vacuum, and dissolve the residue in 2 ml of water containing m-cresol internal standard. Column: Waters Resolve C18, 150 3.9 mm, equipped with Symmetry C18 guard column. Mobile phase: Solvent A = phosphate buffer, p 5.81; solvent B = acetonitrile; solvent C = water. %C 0 15 81 79 19 21 0 15 24.5 79 73.7 21 26.3 0 24.5 29 73.7 73 26.3 27 0 29 43 73 66 27 34 0 43 47 66 64 34 36 0 47 54 64 57 36 43 0 54 55 57 0 43 85 0 15 55 59 0 85 15 Flow rate: 1.15 ml/minute Injection volume: 5 μl Detection wavelength: 203 nm

0048 - Ginseng for Ginsenosides by PLC 3 Linearity: Not specified Accuracy: Not specified Precision: 1.1% to 8.7% RSD, depending on ginsenoside (six determinations). selectivity was confirmed by comparing results with those obtained using a different chromatographic system. Ruggedness: Not specified Robustness: Not specified LOD/LOQ: Not specified Method 2: The Institute for Nutraceutical Advancement (INA) developed a reversed-phase gradient PLC method2 for the determination of ginsenosides in ginseng roots and extracts Extract a standardized extract (about 90 mg) or ground root (about 800 mg) with 25 ml of ethanol water (50:50) by sonicating and shaking at 50oC. Cool, add about 10 ml of acetonitrile, and dilute the sample to 50 ml with water. Column: YMC ODS-A, 3 μm, 3.0 150 mm. Mobile phase: Solvent A = water, solvent B = acetonitrile. 0 22 80 78% 20 22% 22 40 78 50% 22 50% 40 50 50 45% 50 55% 50 52 45 35% 55 65% Flow rate: 0.6 ml/minute Injection volume: 12 μl Detection wavelength: 205 nm Linearity: 0.5 to 60 mcg/ml for each ginsenoside; correlation coefficient 0.99978 to 1.00000, depending on ginsenoside. RSD of response factors: 3.37% to 9.61%, depending on ginsenoside. Accuracy: Ginseng extracts and root material were spiked with a ginseng extract of known ginsenoside content at the 150% and 200% target. The percent recoveries were calculated and ranged from 98.5 to 106.3. Precision: 1.47% RSD for extract sample (total ginsenosides; six determinations). 1.74% RSD for root sample (total ginsenosides; six determinations). Ruggedness: Three different laboratories analyzed six sets of samples. The percent RSD between the three laboratories for each sample was: Sample 1 = 5.6%; Sample 2 = 2.1%; Sample 3 = 4.6%; Sample 4 = 5.3%; Sample 5 = 5.0 %; and Sample 6 = 0.7%. Robustness: Not determined LOD/LOQ: LOD = 0.348 to 1.58 mcg/ml, depending on the ginsenoside; LOQ = 1.16 to 5.27 mcg/ml, depending on the ginsenoside.

4 0048 - Ginseng for Ginsenosides by PLC Method 3: Li and Fitzloff 3 developed an PLC method with evaporative light-scattering detection (ELSD) to overcome the limitations of poor sensitivity associated with low-wavelength UV detection. Extract about 0.5 g of ground root with three 15-mL portions of methanol in a 50-mL volumetric flask using sonication and shaking at 25 to 30oC for 30 minutes. Combine the methanol extracts and dry. Reconstitute the residue in methanol, and bring to volume in a 10-mL volumetric flask. Column: Waters Spherisorb ODS-2 C18, 250 4.6 mm. Mobile phase: Solvent A = water, solvent B = acetonitrile. 0 20 80 20 20 60 80 58 20 42 60 61 58 10 42 90 Flow rate: 1.6 ml/minute Injection volume: 10 μl Detection: Sedex 75 ELSD; evaporation chamber temperature = 35oC; nebulizing gas pressure = 3.4 bar. Linearity: 20 to 200 mcg/ml for each ginsenoside; correlation coefficient 0.9976 to 0.9998, depending on the ginsenoside. Accuracy: No spiking studies were performed. Precision: 4.23 to 9.89% CV, depending on ginsenosides; three determinations, control sample. Ruggedness: Not determined Robustness: Not specified LOD/LOQ: LOD = 50 ng for each ginsenoside; LOQ = not specified. Method 4: Gomez-Serranillos et al. 4 developed a rapid, sensitive PLC UV method with solid-phase extraction (SPE) sample cleanup. The SPE step removes many interfering peaks, increasing the sensitivity of the method while allowing for a shorter run time. Extract ground ginseng root sample or powdered ginseng tablets with methanol water (70:30) at room temperature for 30 minutes. Evaporate the solution and reconstitute the residue in water. Apply a portion of the aqueous solution to a Waters Sep-Pak C18 cartridge. Wash the cartridge with water, and follow by methanol water (30:70). Elute the ginsenosides with methanol. Evaporate the eluate and reconstitute the residue with methanol water (30:70). Column: ypersil ODS, 5 m, 4.6 200 mm. Mobile phase: Solvent A = water acetonitrile (90:10), solvent B = acetonitrile.

0048 - Ginseng for Ginsenosides by PLC 5 0 20 75 50 25 50 Flow rate: 2.0 ml/minute Injection volume: 10 μl Detection wavelength: 205 nm Linearity: Not specified Accuracy: Not specified Precision: Not specified Selectivity: Peak identification of Rb1, Rb2, Rc, Rd, Re, Rf, and Rg1 was made against standards. In addition, Ruggedness: Not specified Robustness: The method was tried on three different brands of C18 columns with comparable results. LOD/LOQ: Not specified References: 1. Court WA, endel JG, Elmi J. Reversed-phase high-performance liquid chromatographic determination of ginsenosides in Panax quinquefolium. J Chromatogr A. 1996;755:11 7. 2. Institute for Nutraceutical Advancement. Panax and American ginseng assay by PLC. Available at: http://www.nsf.org/business/ina/ index.asp?program=ina. 3. Li WK, Fitzloff JF. PLC analysis of ginsenosides in the roots of Asian ginseng (Panax ginseng) and North American ginseng (Panax quinquefolium) with in-line photodiode array and evaporative light scattering detection. J Liq Chromatogr Relat Technol. 2002;25(1):29 41. 4. Gomez-Serranillos MP, Palomino OM, Carretero E, et al. A new PLC method for the analysis of ginsenosides in Panax ginseng. Fitoterapia. 1997;68(6):533 6.