The proposed hptlc method is less expensive, simpler, rapid and more precise than reported hplc method for routine analysis of voglibose and metformin hydrochloride in bulk drug and tablet dosage forms. Voglibose is an alphaglucosidase inhibitor widely used for the treatment of diabetes. Voglibose in pharmaceutical preparations is best analyzed using hplc with postcolumn derivatization. Analysis of voglibose in pharmaceutical formulations by hplc. Voglibose has no inhibitory activity against lactase and so, it does not cause lactose intolerance and diarrhoea. Voglibose analysis columns gard column protection system the new gard uses a proprietary material to prevent matrix compounds from passing through and thereby protecting the analytical column, but allows the analytes of interest to pass unimpeded through the gard and onto the analytical continue reading voglibose analysis columns. Results of analysis were validated statistically in accordance with ich. A rphplc method development and validation for the. Analysis of voglibose by postcolumn fluorometric detection. Voglibose treatment has resulted in an increased release of glp1, which is an insulinotrupic hormone and it has also increased release of glp1, which is known to enhance insulin secretion and insulin sensitivity. Despite that, several groups have studied its effects on postprandial glucose levels and on insulin and cpeptide content in patients with type ii diabetes. According to the preparation method of the voglibose intermediate, the integral synthetic process is low in solvent toxicity, simple in posttreatment operation, short in reaction time, low in cost, high in product yield, good in quality, suitable for industrialized production and the like. Dec 15, 20 voglibose treatment has resulted in an increased release of glp1, which is an insulinotrupic hormone and it has also increased release of glp1, which is known to enhance insulin secretion and insulin sensitivity.
The method was further optimized and validated in accordance with guidelines suggested by international conference on harmonization ich. Simultaneous quantification of voglibose and metformin by validated analytical method in tablet dosage form raj neha. Stabilityindicating rplc method for the determination of vildagliptin and mass spectrometry detection for a main degradation product. Comparison of effects of sitagliptin and voglibose on left. Voglibose, glimepiride in bulk and combined tablet dosage. The developed method employs multi component spectroscopy using 325nm, 285nm, 245nm and 205nm as wavelengths for estimation. According to jp japanese pharmacopoeia method, purity test of voglibose, it is necessary for the system suitability to satisfy theoretical plate number of. Fast separation of metformin and voglibose using a thermo. The invention also relates to pharmaceutical compositions that include the pure voglibose or voglibose hydrochloride and use of said compositions for treatment or prevention of hyperglycemic symptoms and various disorders caused by hyperglycemia such as diabetes, obesity, and hyperlipemia. Separation of metformin and voglibose using a thermo scientific accucore hilic hplc column krishna rao dara, prakash chander, dr. The invention relates to processes for the preparation of pure voglibose. Determination of caffeine by hplc introduction it was a long history before real high performance liquid chromatography hplc had evolved. High pressure liquid chromatography 20 chem 4 introduction chromatography can be described as a mass transfer process involving adsorption using a nonpolar stationary phase and a mobile polar phase titrating through the column.
Rp hplc method development and validation for estimation of voglibose in bulk and tablet dosage forms article pdf available in international journal of research in pharmaceutical sciences 12. Jun 19, 2015 left ventricular lv diastolic dysfunction is frequently observed in patients with type 2 diabetes. This free service is available to anyone who has published and whose publication is in scopus. Determination of voglibose in pharmaceutical formulations by high. Separation science offers free learning from the experts covering methods, applications, webinars, eseminars, videos, tutorials for users of liquid chromatography, gas chromatography, mass spectrometry, sample preparation and related analytical techniques. Analytical method development and validation for the. Voglibose and metformin in combined tablet dosage form has been. This free service is available to anyone who has published and whose. Dec 29, 2014 the aim of this study was to compare the pharmacokinetic characteristics of metformin between a fixeddose combination fdc of voglibose metformin and coadministered individual voglibose and metformin tablets in healthy korean volunteers under fasting. Has received insulin, voglibose, acarbose or other oral hypoglycemic drugs except metformin for accumulative total of more than 7 days within the latest 3 months prior to visit 1. Sensitive lcmsms liquid chromatography tandem mass spectrometric method for the. Tushar n mehta, centre of excellence for asia pacific laboratory, thermo fisher scientific, ahmedabad, india introduction voglibose is an aglucosidase inhibitor, used as an. Rp hplc method for the estimation of voglibose in bulk drug and tablet. Fast separation of metformin and voglibose using a thermo scientific accucore hilic hplc column be the first to rate this application.
K college of pharmacy, chennai, tamil nadu, india abstract. Prasad babu department of pharmaceutical analysis, k. Double distilled water was used as solvent throughout the study. Left ventricular lv diastolic dysfunction is frequently observed in patients with type 2 diabetes. Pharmacokinetic study of metformin to compare a voglibosemetformin fixeddose combination with coadministered voglibose and metformin. The shimadzu voglibose analysis system is the industrys benchmark providing superior method capability to comply with the regulated methods. Hplc postcolumn derivatization is specified as the test method for voglibose in the. The specificity of the hplc method is excellent and sufficient precision is also simultaneously attainable. Useful data is provided throughout the book, such as. Rphplc method for the estimation of voglibose in bulk drug and tablet. It remains unclear whether dpp4i improves lv diastolic function in patients with type 2 diabetes, and, if so, it is attributable to the attenuation of pph or to a. Pdf voglibose is a potent glucosidase inhibitor used for type ii diabetes mellitus. More particularly, it relates to the preparation of crystalline hydrochloride salt of voglibose. Alphaglucosidase inhibitors are agents that delay the glucose absorption at the intestinal level and thereby prevent sudden surge of glucose after a meal.
Analytical method development and validation of metformin, voglibose, glimepiride in bulk and combined tablet dosage form by gradient rp hplc pharmaceutical methods vol 5 issue 1 janjun 2014 29 time programming of the gradient elution used to determine met, vog and gli is given in table 1. The most downloaded articles from journal of pharmaceutical analysis in the last 90 days. Analysis of voglibose according to jp method nh2p50 4e according to jp japanese pharmacopoeia method, purity test of voglibose, it is necessary for the system suitability to satisfy theoretical plate number of. Comparison of elisa and hplcms methods for the determination of exenatide in biological and biotechnologybased. Contact information for japanese pharmacopoeia seventeenth edition jp17 name and structure database. Stabilityindicating rphplc method for determination of. Wo2005030698a1 process for the preparation of voglibose. Estimation of metformin hydrochloride and voglibose in. A simple, specific, precise, and efficient method for the.
Most downloaded journal of pharmaceutical analysis articles. All eligible subjects provided written informed consent to participating and were free to withdraw from the study at any time without obligation. Novel rp hplc method development and validation for simultaneous estimation of metformin, voglibose and pioglitazone in bulk and triple fixed drug combinations pharmaceutical dosage form. A simple, sensitive, linear, precise, and accurate method by gradient reversedphasehigh performance liquid chromatography for the simultaneous estimation of metformin met, voglibose vog and glimepiride gli in bulk and in their combined tablet dosage form was developed and validated. Materials and methods chemicals and reagents the pure api samples of sitagliptin phosphate and simvastatin were obtained as free gift samples from. Pharmacokinetic study of metformin to compare a voglibose. Development and validation of a stabilityindicating rp. Pdf determination of voglibose in pharmaceutical formulations by. Simultaneous quantification of voglibose international journal of. This abstract was viewed 1551 times pdf article downloaded 730 times. A simple reversedphase highperformance liquid chromatography method was developed and validated for simultaneous determination of metformin hydrochloride met and glimepiride glm in combination and estimation of their principal degradation products. Voglibose is known to have a very high watersolubility and, therefore, a fast dissolution of this drug is expected. Development and validation of a stabilityindicating rpuplc. Voglibose ao128 is not as widely studied as acarbose, the latter being the first representative.
The results showed that voglibose tablets had good content uniformity. Voglibose and metformin in the form of gift samples were kindly supplied by bioplus life sciences, micro labs ltd, bangalore respectively. Voglibose is an antidiabetes drug which inhibits the activity of. The active component of the column, the sorbent or the stationary phase, is typically a granular.
Stabilityindicating rplc method for the determination of. In addition to providing an introduction to hplc for pharmaceutical analysis it is intended that this book will be a useful resource. Development of a rapid method for the determination of glimepiride in human plasma. High performance liquid chromatography hplc is an advanced. A simple, accurate, economical and reproducible uv spectrophotometric method for simultaneous estimation of voglibose and metformin in combined tablet dosage form has been developed.
Voglibose is a diabetes drug which inhibits the activityof. Reversedphase highperformance liquid chromatography rphplc has been the most widely used method for pharmaceutical analysis, as it ensures accurate quantification of drugs without interference from any of the excipients that are normally present in pharmaceutical dosage forms. Ymctriart c18 has been developed and is manufactured using stateoftheart technologies that define materials, granulation. Method development and validation for determination of. Rphplc analysis of metformin hydrochloride and voglibose and study of its different analytical parameter html full text.
Pdf rphplc method development and validation for estimation. Sensitive lcmsms method for the simultaneous determination of. Alphaglucosidase inhibitors are agents that delay the glucose absorption at the intestinal level and thereby prevent sudden surge of glucose. Analytical method development and validation of metformin,voglibose, glimepiride in bulk and combined tablet dosage form by gradient rphplc pharmaceutical methods vol 5 issue 1 janjun 2014 29 time programming of the gradient elution. Method development and validation for determination of voglibose. The aim of the study is to develop a simple, precise and accurate reversephase hplc method for the estimation of gliclazide in pharmaceutical dosage form as per ich guidelines. Quantitative determination of voglibose in pharmaceutical. Development and validation of stabilityindicating rphplc. Analysis of voglibose by postcolumn fluorometric detection method this application news introduces an example ofanalyzing voglibose using the shimadzu lcvpreducing sugar analysis system with the postcolumnfluorescence derivatization method withtaurine periodic acid reagent.
Applications of the prominence rf20axs fluorescence. Pdf novel rphplc method development and validation for. Tswett on the separation of plant pigments using powdered calcium carbonate. Here we introduce an example of voglibosetablet testing as specified in the japanesepharmacopeia, fifteenth edition. Rp hplc analysis of metformin hydrochloride and voglibose and study of its different analytical parameter html full text.
Development and validation of a repharsed phase hplc. Publish with chemistrycentral and every scientist can read your work free of charge open access provides opportunities to our colleagues in other parts of the globe, by allowing anyone to view the content free of charge. The invention also relates to pharmaceutical compositions that include the pure voglibose or voglibose hydrochloride and use of said. L406 applications of the prominence rf20axs fluorescence detector part 5 analysis of voglibose with postcolumn derivatization system voglibose is a diabetes drug which inhibits the activity of. Analytical method development and validation of metformin. Method development and validation for determination 1772 different batches of voglibose, three coded as a, b and c with dosage of 0. The novel reverse phasehigh performance liquid chromatography rphplc, stability indicating method was developed for determination of linagliptin lgp and its related substances in linagliptin and metformin hcl met hcl tablets by implementing design of experiment to understand the critical method parameters and their relation with critical method attributes. Ma 327 analysis of voglibose in pharmaceutical formulations click here download this material in a pdf format by hplc with postcolumn derivatization voglibose is an alphaglucosidase inhibitor widely used for the treatment of diabetes. Results of analysis were validated statistically in accordance with ich guidelines. Novel rphplc method development and validation for simultaneous estimation of metformin, voglibose and pioglitazone in bulk and triple fixed drug combinations pharmaceutical dosage form. The chromatographic separation was performed on a c18 column employing 0.
Quantitative determination of voglibose in pharmaceutical tablets using highperformance liquid chromatographyfluorescence detection with postcolumn derivatization and mass spectrometric detection. A simple, economic, selective, precise, and stabilityindicating hplc method has. Efficacy and safety of voglibose compared with acarbose in participants with type 2 diabetes the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The separation is performed on a thermo scientific accucore hilic hplc column, with ms detection. Voglibose pure sample was kindly provided by torrent pharmaceutical pvt ltd. Rphplc method development and validation for estimation. Analysis of voglibose according to jp method nh2p50 4e. A new stabilityindicating rphplc method for the determination of metformin hydrochloride and nateglinide in tablets was developed.
Determination of voglibose in pharmaceutical formulations by high performance liquid chromatography using. Reversedphase c18 columns ods versatile hybrid silica based hplc column ymctriart c18 ymctriart c18 is a hybrid silica based ods column emphasizing durability, low operating pressure, and excellent performance. Simultaneous quantification of voglibose and metformin by. Met estimated in the tablet dosage form were free from the interference of excipients. High performance liquid chromatography hplc is an advanced form of liquid chromatography used in separating complex mixtures of molecules encountered in chemical and biological systems. A new stability indicating reverse phase high performance liquid chromatography rphplc 20 method was developed and validated under current international conference of 21 harmonisation ich guidance for the determination of prednisolone acetate pac and 22 impurities in an ophthalmic suspension.
The hplc system, agilent 1120 compact with manual rheodyne. Most of the documents on the literature is available in pdf format. Hplc postcolumn derivatization isspecified as the test method for voglibose in thejapanese pharmacopeia, fifteenth edition voglibosepurity test, quantitation of voglibose in pharmaceuticaltablets. At the end of each chapter there is a list of references andor further reading which will help the reader to develop their expertise in the technique. Listing a study does not mean it has been evaluated by the u. Stabilityindicating rplc method for the determination of vildagliptin and mass spectrometry detection for a main degradation product amanda thomas barden postgraduate program in pharmaceutical sciences, federal university of rio grande do sul, porto alegrers, brazil.
It relies on pumps to pass a pressurized liquid solvent containing the sample mixture through a column filled with a solid adsorbent material. Voglibose is the safest and most effective drug of its class. Most downloaded journal of pharmaceutical analysis. Development and validation of a new stability indicating.
The invention also relates to the preparation of acid addition salts of voglibose. Rphplc method development and validation for estimation of voglibose in bulk and tablet dosage forms article pdf available in international journal of research in pharmaceutical sciences 12. Rphplc method development and validation for estimation of. Pdf simultaneous quantification of voglibose and metformin. An rp hplc method for the simultaneous estimation of metformin hcl and voglibose tablets was developed and validated in micro labs in hosur.
The very first indication of a chromatographic separation was introduced in 1903 by the russian botanist m. Description the thermo scientific hplc system is applied for the determination of metformin and voglibose. Separation of metformin and voglibose using a thermo. The separation of the three drugs was based on the use of inertsil. This application news introduces an example ofanalyzing voglibose using the shimadzu lcvpreducing sugar analysis system with the postcolumnfluorescence derivatization method withtaurine periodic acid reagent. Dipeptidyl peptidase4 inhibitor dpp4i attenuates postprandial hyperglycemia pph and may have cardioprotective effects. Efficacy and safety of voglibose compared with acarbose in participants with type 2 diabetes. The dissolution of voglibose was almost complete 30 min after initiation of the dissolution test at a paddle speed of 50 rpm in water. Pdf a simple, sensitive, precise and specific reverse phase high. The proposed hptlc method is less expensive, simpler, rapid and more precise than reported hplc method for routine analysis of voglibose and metformin. Efficacy and safety of voglibose compared with acarbose in.