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. Rphplc method development and validation for estimation of. We have been tried to use hplc with 500 ml medium but the final concentration was too low to detect. Abstract a simple, rapid, precise and reliable rphplc method was developed for estimation of voglibose vog and mitiglinide calcium hydrate mgn in pharmaceutical dosage form.
Development and validation of a stability indicating hplc. Aichrom series hplc column is one of the proud products of abel. Rp hplc analysis of metformin hydrochloride and voglibose and study of its different analytical parameter abstract. Determination of voglibose in pharmaceutical formulations by high. Inulin and oligofructose exhibit valuable nutritional and functional attributes, and so the utilization of inulin and its derivatives in the food industry has been continuously increasing. The shimadzu voglibose analysis system is the industrys benchmark providing superior method capability to comply with the regulated methods. 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. The developed rphplc method was sensitive and selective for estimation of metformin, voglibose and pioglitazone in combined dosage form.
Quantitative determination of voglibose in pharmaceutical. Voglibose is known to have a very high watersolubility and, therefore, a fast dissolution of this drug is expected. High performance liquid chromatography hplc was developed in the late 1960s and early 1970s. While comparing the efficacy and safety of acarbose and voglibose in 30 subjects, both were observed to decrease 1h postprandial blood glucose levels, from 224. High performance liquid chromatography optimized for rapid high resolution separationsvery high efficiency hplc columns with inert packing materials fine particle packing 5m providing larger surface for interaction hplc high pressure pumps with very constant flow 60000 psi unique high accuracy, low dispersion, hplc sample valves. Introduction typically, wine is made by the fermentation of grapes that have been crushed to extract the juice. Then, only the fraction that contains the target compounds. A simple, specific, sensitive, precise and accurate reverse phase high performance liquid chromatographic method rphplc was developed for the simultaneous analysis of metformin and saxagliptin in active pharmaceutical ingredients apis as well as in marketed tablet combination dosage forms. 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.
Highperformance liquid chromatography hplc is a method that introduces the mobile phase under highpressure conditions that results in rapid and highperformance separations. 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. A new stability indicating reversed phase high performance liquid chromatography rphplc method was developed and validated under current internatio. Voglibose can cause side effects such as diarrhea, flatulence, skin reactions. Development and validation of rphplc method for simultaneous. Fruit wine analysis by hplc application note author stephen ball agilent technologies, inc. Us7619102b2 us11816,439 us81643906a us7619102b2 us 7619102 b2 us7619102 b2 us 7619102b2 us 81643906 a us81643906 a us 81643906a us 7619102 b2 us7619102 b2 us 7619102b2 authority us united states prior art keywords mupirocin method according step organic solvent acid prior art date 20050221 legal status the legal status is an assumption and is not a. Chromatographic separation was achieved on a kinetics c 18 column 250. Hplc postcolumn derivatization is specified as the test method for voglibose in the japanese pharmacopeia, fifteenth edition voglibose.
A new stability indicating reversed phase high performance liquid chromatography rp hplc method was developed and validated under current internatio. Voglibose was first launched in 1994, under the trade name basen, to improve postprandial hyperglycemia in diabetes mellitus. Method development and validation for determination 1772 different batches of voglibose, three coded as a, b and c with dosage of 0. Development and validation of a repharsed phase hplc method. Hplc, metformin hcl, voglibose and glimepiride, method development. Development and validation of a repharsed phase hplc. Method development and validation for determination of voglibose. A simple, specific, sensitive, precise and accurate reverse phase high performance liquid chromatographic method rp hplc was developed for the simultaneous analysis of metformin and saxagliptin in active pharmaceutical ingredients apis as well as in marketed tablet combination dosage forms.
The aim of this paper was to develop a simple and validated rp hplc method for simultaneous estimation of pioglitazone hcl pgz and glimepiride glm in tablet dosage form. The accuracy of an analytical procedure expresses the closeness of agreement between the value that is accepted either as a conventional true value or as an accepted reference value and the value found. Development and validation of a new stability indicating reversed phase liquid chromatographic method for the determination of prednisolone acetate and impurities in an ophthalmic suspension. Acarbose and voglibose are alphaglucosidase inhibitors. Jan 26, 2012 rosiglitazone roz and glimepiride glm are antidiabetic agents used in the treatment of type 2 diabetes mellitus. Comparison of the effects of acarbose and voglibose in healthy subjects. The main text of the article should start with title, authors name, institute name and address, email address, phone and fax number of. Voglibose is a research product of takeda pharmaceutical company, japans largest pharmaceutical company. Left ventricular lv diastolic dysfunction is frequently observed in patients with type 2 diabetes. Comparison of effects of sitagliptin and voglibose on left. If any side effects of voglibose develop or change in intensity, the doctor should be informed as soon as possible. Rp hplc analysis of metformin hydrochloride and voglibose and study of its different analytical parameter html full text. A comparative study of highperformance liquid chromatography. Test of related substances and determination of contents in.
Method development, validation and forced degradation. It is pertinent to note that side effects of voglibose cannot be anticipated. The main text of the article should start with title, authors name, institute name and address, email address, phone and fax number of corresponding author on one title page, followed by abstract, keywords, introduction, materials and methods, results, discussion, acknowledgments and references. Ionexchange ie hplc separates fulllength oligonucleotides from truncated species based on relative charge. Method development, validation and forced degradation studies. A rp hplc method has been developed and validated for the quantification of bupivacaine in human plasma. Pdf determination of voglibose in pharmaceutical formulations by. In the first step, the sample is roughly separated in the pretreating column. In addition to providing an introduction to hplc for pharmaceutical analysis it is intended that this book will be a useful resource. 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. 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. Today it is widely applied for separations and purifications in a variety of areas including pharmaceuticals, biotechnology, environmental, polymer and food industries. Hplc ebook page 14 introduction to high performance liquid chromatography and its parts the only source of knowledge is experience albert einstein chromatography equipment look rather intimidating to anyone who has not handled them before, but on a closer look and as you get familiar with the equipment you realize that behind the. But hplc is only suitable for analysis of substances soluble in npentane 1.
The proposed method has adequate sensitivity, reproducibility and specificity for the determination of voglibose in bulk and its tablet dosage forms. Shimadzu automatic sample pretreatment hplc system is recommended. The novel reverse phasehigh performance liquid chromatography rp hplc, 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. Voglibose is an antidiabetes drug which inhibits the activity of. The calibration curve for voglibose was linear from 100 to 500ngml. 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. Pharmaceutical grade working standard voglibose and metformin were obtained from syncorp pvt. Validation of hplc technique authorstream presentation. This application news introduces an example ofanalyzing voglibose using the shimadzu lcvpreducing sugar analysis system with the postcolumnfluorescence. Selected mobile phase was in a combination of acetonitrile. Hplc system with automatic sample pretreatment functions this system is used for analysis of samples that contain many interfering compounds. Comparison of the effects of acarbose and voglibose in.
High performance liquid chromatography hplc, a form of column chromatography, can be performed in one of two ways. Voglibose and metformin, hplc, method development, ich, validation, accuracy, precision. A hplc equipped with a variable wavelength uv detector 14. Click the get adobe reader icon on the left to download a free copy of adobe acrobat reader. The column hold up value was the first deviation of the base line obtained. This is a cheaper method than using grapes and is therefore becoming more popular. Voglibose is a research product of takeda pharmaceutical company, japans largest pharmaceutical. Hplc has over the past decade become the method of choice for the analysis of a wide. Do you have any suggestion for dissolution testing methodconfused. Hplc postcolumn derivatization isspecified as the test method for voglibose in thejapanese pharmacopeia, fifteenth edition voglibosepurity test, quantitation of voglibose in pharmaceuticaltablets. Voglibose in pharmaceutical preparations is best analyzed using hplc with postcolumn derivatization. This application news introduces an example ofanalyzing voglibose using the shimadzu lc. Test of related substances and determination of contents. 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.
There are many analytical methods available for estimation of glimepiride in biological samples and pharmaceutical preparations. Optimized column is a stainless steel column packed with base octa. Voglibose delays the absorption of glucose thereby reducing the risk of macrovascular complications. Instructions to authors download authors instructions. The various interaction s between the analyte, stationary phase packing material, and mobile phase are the key factors for the separation. The dissolution of voglibose was almost complete 30 min after initiation of the. This abstract was viewed 1569 times pdf article downloaded 736 times. 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.
Analysis of voglibose by postcolumn fluorometric detection. However, wine can also be made from other fruit juices. The application of high performance liquid chromatography hplc to hydrocarbon grouptype analysis is characteristic with its high efficiency, high speed, and high sensitivity. Voglibose is a diabetes drug which inhibits the activityof. Download pdf journal of drug delivery and therapeutics. Using sodium octanesulfonate phosphate buffer solution as the mobile phase,the analysis was carried out on an ods column. The active component of the column, the sorbent or the stationary phase, is typically a granular. A uplcdad method for simultaneous determination of. Unique hardware geometry reduces peak broadening and delivers excellent peak shapes. A hplc post column derivation fluorescence detection method has been developed for the test of related substances and determination of contents in voglibose tablets. A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of voglibose in bulk and tablet dosage forms.
However the reported method suffers from the low sensitivity, for this reason, our target was to develop. Aichrom series hplc columns provide the superior performance in terms of efficiency, resolution, peak shape and customer application competability. Rphplc analysis of metformin hydrochloride and voglibose and study of its different analytical parameter abstract. The results showed that voglibose tablets had good content uniformity. 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. Reversephase rp hplc separates fulllength oligo product from truncated products based on relative hydrophobicity. Applications of the prominence rf20axs fluorescence. Applications of the prominence rf20axs fluorescence detector. Method development and validation for determination of.
Jun 19, 2015 left ventricular lv diastolic dysfunction is frequently observed in patients with type 2 diabetes. Highperformance liquid chromatography hplc scope instrumentation eluants, injectors, columns modes of hplc partition chromatography adsorption chromatography ion chromatography size exclusion chromatography. A simple, rapid and sensitive ultrahigh performance liquid chromatographic method was developed for the determination of the antidiabetic drug. Listing a study does not mean it has been evaluated by the u. Compared with highperformance liquid chromatography hplc which presents improved sensitivity and precision, colorimetric method is more widely used and accepted due to the advantages of its simplicity and. Each participant was required to dilute the test solutions and the spiked ones and to perform a single analysis of. 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 voglibose is a potent glucosidase inhibitor used for type ii diabetes mellitus.
A coupledcolumn hplc system, consists of one reversedphase and one ionexchange column. Development and validation of rphplc method for glimepiride. Useful data is provided throughout the book, such as. Pdf rphplc method development and validation for estimation. 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. Hi all i have been researching on voglibose tablet that is a lowdose oral disintegrating tablet odt. The hplc system is lc10a shimadzu, kyoto, japan consisted of a pump lc10, uv detector spd10av and autoinjector sil10 a xl column. The determination of voglibose feasible by derivatization with chromoaphoric. International journal for pharmaceutical research scholars ijprs brings a whiff of fresh ideas based on scholarly research topics for all those who want to learn and share information pertaining to the pharmaceutical industry. Here we introduce an example of voglibosetablet testing as specified in the japanesepharmacopeia, fifteenth edition. Ultrafast separations on conventional hplc systems. Development and validation of a method for simultaneous. Dipeptidyl peptidase4 inhibitor dpp4i attenuates postprandial hyperglycemia pph and may have cardioprotective effects.
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