Alphaglucosidase inhibitors are agents that delay the glucose absorption at the intestinal level and thereby prevent sudden surge of glucose after a meal. Jan 07, 2014 it is a drug used to prevent type 2 diabetes when there is impaired glucose tolerance, in japan. Voglibose is a research product of takeda pharmaceutical company, japans largest pharmaceutical. Oct 17, 2016 this work aims to develop hplc dad method for linagliptin lng quantitation in the presence of its degradation products in tablets and to study its we use cookies to enhance your experience on our website. However the reported method suffers from the low sensitivity, for this reason, our target was to develop. Voglibose api japan drug master files pharmacompass. Analytical method development and validation of metformin. If you do not have adobes acrobat reader, you can download it here.
Applications of the prominence rf20axs fluorescence detector. K college of pharmacy, chennai, tamil nadu, india abstract. The active component of the column, the sorbent or the stationary phase, is typically a granular. Kasad, shree dhanvantary pharmacy college, department of quality assurance, kim, surat 394110 i ndia corres. The column hold up value was the first deviation of the base line obtained.
Three reversedphase fusedcore hplc columns halo rpamide, halo c18 and halo phenylhexyl, all thermostated at 30c, were evaluated. Voglibose is being tested to treat type 2 diabetes in people who have diabetes that is inadequately controlled on metformin alone. The thermo scientific hplc system is applied for the determination of metformin and voglibose. Chapter1 introduction to analytical techniques and drugs.
Eligible participants will be randomly assigned by chance, like flipping a coin to one of the two treatment groups. The determination of rotenone in municipal and industrial wastewaters by hplcuv instrument. This study will look at glycemic control in people who take voglibose. Rphplc method development and validation for estimation. It was in the year 1980, hplc methods appeared for the. Applications of the prominence rf20axs fluorescence. Linagliptin lng, 83r3aminopiperidin1yl7but2yn1yl3methyl14methylquinazolin2yl methyl3,7dihydro1hpurine2,6dione, is a selective, competitive dipeptidyl peptidase4 dpp4 inhibitor, that was approved in 2011 by usa, japan and europe for the treatment of type 2 diabetes figure 1.
We have application notes, application news, technical reports, and many other types of documents. A simple, specific, precise, and efficient method for the. La554 analysis of voglibose by post column hplc under the condition of japanese pharmacopoeia application search analysis of voglibose by post column hplc under the condition of japanese pharmacopoeia category document no. Voglibose delays the absorption of glucose thereby reducing the risk of macrovascular complications.
Quantitative determination of headache tablets the chromatograph you will be using can best be viewed as a series of components. The results showed that voglibose tablets had good content uniformity. La554 analysis of voglibose by post column hplc under. In literature only one article for the determination of vb was found.
All reagents and solvents should be of analytical grade. Single laboratory accuracy and precision data have been determined for this method. The hplc system is lc10a shimadzu, kyoto, japan consisted of a pump lc10, uv detector spd10av and autoinjector sil10 a xl column. Analysis of voglibose in pharmaceutical formulations by hplc with postcolumn derivatization voglibose is an alphaglucosidase inhibitor widely used for the treatment of diabetes. Please, select more pdf files by clicking again on select pdf files. Z z o development and validation of stability indicating. Any modification of this method beyond those expressly permitted shall be considered a major modification. Method development and validation for determination 1772 different batches of voglibose, three coded as a, b and c with dosage of 0. Abstract a simple, rapid, precise and reliable rp hplc method was developed for estimation of voglibose vog and mitiglinide calcium hydrate mgn in pharmaceutical dosage form. Stability indicating rp hplc method for estimation of voglibose in bulk and tablet dosage form shubhangi c. If any side effects of voglibose develop or change in intensity, the doctor should be informed as soon as possible. Content 2 1152017 mercachem analytical department purification and recovery recovery problems. Method development and validation for determination of.
Waters alliance 2695 hplc system with waters 2487 dual absorbance uvvis detector 1. Stabilityindicating hplcdad method for the determination of. Solvent reservoirs a pump b column compartment c detector module d injector e console studio. Separation of metformin and voglibose using a thermo scientific accucore hilic hplc column krishna rao dara, prakash chander, dr.
Optimized column is a stainless steel column packed with base octa. An hplc system consists of a pumping unit, sampleinjection unit, separation unit, detection unit, and dataprocessing unit. Voglibose is known to have a very high watersolubility and, therefore, a fast dissolution of this drug is expected. Rphplc method development and validation for estimation of voglibose in bulk and tablet dosage forms april 2010 international journal of research in pharmaceutical sciences 12. 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.
All participants will be enrolled in a 2week screening phase and a metformin runin phase. Stabilityindicating hplcdad method for the determination. A rapid stabilityindicating, fusedcore hplc method for. This page is designed to help you navigate the large quantity of literature available on our website.
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. Hplc postcolumn derivatization is specified as the test method for voglibose in the japanese pharmacopeia, fifteenth edition voglibose. Research article development and validation of rphplc. Asked 7 jan 2014 by shaikshahabuddin updated 7 january 2014 topics dosage. The developed rphplc method was found to be simple, rapid, selective, accurate and precise for the concurrent estimation of drugs in twocomponent tablet dosage form of gliclazide and metformin. Standard operating procedure thermo scientific ultimate. Method of analysis for vitamins fatsoluble vitamins, such as vitamins e, d, and a, and watersoluble vitamins, such as. Standard operating procedure thermo scientific ultimate 3000. Selected mobile phase was in a combination of acetonitrile. Voglibose is a research product of takeda pharmaceutical company, japans largest pharmaceutical company. The determination of rotenone in municipal and industrial.
Development and validation of rp hplc method for the simultaneous estimation of miglitol and metformin hcl in pharmaceutical formulations srinivas ampati1, sandeep dyavarashetti1, kiran gangarapu2 1department of pharmaceutical analysis, s. Development and validation of analytical method for. Development and validation of lc methods with visible. A simple, precise and accurate rp hplc method has been developed and. We have been tried to use hplc with 500 ml medium but the final concentration was too low to detect. Purifying by preparative hplc how can we improve the recovery of our sample colinda van tilburg 1 recovery of prep lcms 1152017 group leader analytical chemistry oss, 11th may 2017. Development and validation of stability indicating assay. Introduction miglitol mg is an oral antidiabetic drug in the alpha glucosidase inhibitor1, 2. Do you have any suggestion for dissolution testing methodconfused. There are many analytical methods available for estimation of glimepiride in biological samples and pharmaceutical preparations.
Shimadzu hplclc20at,agilent hplc1200 series and waters breeze hplc by different operators using different c 18 columns like zorbax stable bond, poroshell 120 and kromasil with a flow rate 1. Hplc method for the estimation of vildagliptin in bulk and tablet. The separation of the three drugs was based on the use of inertsil. Efficacy and safety of voglibose compared with acarbose in. Voglibose was first launched in 1994, under the trade name basen, to improve postprandial hyperglycemia in diabetes mellitus. Fast separation of metformin and voglibose using a thermo scientific accucore hilic hplc column be the first to rate this application. By continuing to use our website, you are agreeing to our use of cookies. 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. 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.
It is a drug used to prevent type 2 diabetes when there is impaired glucose tolerance, in japan. Tushar n mehta, centre of excellence for asia pacific laboratory, thermo fisher scientific, ahmedabad, india introduction voglibose is an aglucosidase inhibitor, used as an. The shimadzu voglibose analysis system is the industrys benchmark providing superior method capability to comply with the regulated methods. Principle and system configuration of hplc 3 configuration of an hplc system. The method was further validated as per ich guidelines for the parameters like precision, accuracy, sensitivity, and linearity. To change the order of your pdfs, drag and drop the files as you want. Rp hplc analysis of metformin hydrochloride and voglibose and study of its different analytical parameter html full text. 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. Patil college of pharmacy, akurdi, pune411044, maharashtra, india. This application news introduces an example ofanalyzing voglibose using the shimadzu lcvpreducing sugar analysis system with the postcolumnfluorescence derivatization method withtaurine periodic acid reagent. Development and validation of rphplc method for glimepiride.
The experimental conditions for the rphplc method were based on the protocol presented by kapteyn et al. Hi all i have been researching on voglibose tablet that is a lowdose oral disintegrating tablet odt. A novel, simple and economic reverse phase high performance liquid chromatography rphplc method has been developed for the estimation of vildagliptin in bulk and tablet dosage form with greater precision and accuracy. It is also used to reduce the blood sugar after eating in diabetics who have not had full control with other oral meds or insulin. To our knowledge, there is no specific reversephase highperformance liquid chromatography rphplc method for estimation of glimepiride and its dissolution study in selfnanoemulsifying powder snep formulation. That acts by inhibiting the ability of the patient to breakdown complex. It is also used to reduce the blood sugar after eating. Voglibose is an antidiabetes drug which inhibits the activity of.
Jan 30, 2014 this study will look at glycemic control in people who take voglibose. Standard operating procedure thermo scientific ultimate 3000 uhplc instrument. This article describes two liquid chromatographic methods one with. Analytical method development and validation of metformin, voglibose, glimepiride in bulk and combined tablet dosage form by gradient rphplc july 2014 doi. Prasad babu department of pharmaceutical analysis, k. Riboflavin using high performance liquid chromatography hplc for analyzing feed additives content was determined by high performance liquid chromatography hplc with reversedphase and usage of fluorescence detection. Simultaneous determination of metformin and three gliptins in.
A simple, specific, precise, and efficient method for the simultaneous estimation of metformin hcl and voglibose tablet by a reverse phasehigh performance liquid chromatography method is developed and validated. Rphplc method development and validation for estimation of. The separation is performed on a thermo scientific accucore hilic hplc column, with ms detection. Simultaneous determination of metformin and three gliptins. Jan 26, 2012 rosiglitazone roz and glimepiride glm are antidiabetic agents used in the treatment of type 2 diabetes mellitus.
Development and validation of a repharsed phase hplc method. The dissolution of voglibose was almost complete 30 min after initiation of the dissolution test at a paddle speed of 50 rpm in water. Miglitol and metformin, rphplc method, c 18 column, phosphate buffer, method development and validation. It was observed that there were no marked changes in the chromatograms, which demonstrated that the. Each of these units is essential for performing the analysis. Voglibose can cause side effects such as diarrhea, flatulence, skin reactions. Voglibose in pharmaceutical preparations is best analyzed using hplc with postcolumn derivatization. Walode2 and mahendra kumar cb3 1dept of pharmaceutical chemistry, padm.
It is pertinent to note that side effects of voglibose cannot be anticipated. Fast separation of metformin and voglibose using a thermo. Hydrobromide hydrate in pharmaceutical dosage form. Rp hplc method development and validation for estimation of voglibose in bulk and tablet dosage forms april 2010 international journal of research in pharmaceutical sciences 12.
The vaccine was serially diluted in the same manner with standard antigens. Photolyticthermal degradation study and method development of rivaroxaban by rphplc pinaz a. Separation of metformin and voglibose using a thermo. The dissolution of voglibose was almost complete 30 min after initiation of the. It can be used as monotherapy or in combination with other common. Rphplc method for simultaneous estimation of gliclazide. Each participant was required to dilute the test solutions and the spiked ones and to perform a single analysis of. A survey of the literature reveals that only one spectrophotometric method has been reported for the simultaneous determination of ros and glm in pharmaceutical preparations. Development and validation of a repharsed phase hplc. Voglibose 3,4dideoxy42hydroxy1hydroxymethylethylamino2chydroxy methyldepiinositol, vb, is an alphaglucosidase inhibitor used for lowering postprandial blood glucose levels in people with diabetes mellitus. Benfotiamine sbenzoylthiamine omono phosphate is a member of allithiamines group which is a synthetic sacyl derivative.
The developed rp hplc method was found to be simple, rapid, selective, accurate and precise for the concurrent estimation of drugs in twocomponent tablet dosage form of gliclazide and metformin. Development and validation of lc methods with visible detection using precolumn derivatization and mass detection for the assay of voglibose author links open overlay panel nanduri v. Rphplc method for simultaneous estimation of gliclazide and. Voglibose inn and usan, trade name voglib, marketed by mascot health series is an alphaglucosidase inhibitor used for lowering postprandial blood glucose levels in people with diabetes mellitus. 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. R college of pharmaceutical sciences, karimnagar, india. Hplc postcolumn derivatization is specified as the test method for voglibose in the. The retention time was found to metformin hcl and teneligliptin hbr hydrate was found to be 3. Waters alliance 2695 hplc system with waters refractive index detector column. The developed method was validated according to ich guidelines for linear relation including coefficient of correlation, robustness, accuracy and. Quantitation of artemether in pharmaceutical raw material and injections by high performance liquid chromatography.
The pump draws eluent from a reservoir and delivers it to the column. Previous reports of met analysis by reversephase hplc reported the use of sds to increase the retention time of met,33,34 thus, we decided to use sds along with sodium hydrogen phos phate in our method to help fine tune the. Description the thermo scientific hplc system is applied for the determination of metformin and. Merge pdf files combine pdfs in the order you want with the easiest pdf merger available. Quantitative determination of voglibose in pharmaceutical.
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