RP-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Three Drugs: Glimepiride, Pioglitazone, and Metformin and Its Pharmaceutical Dosage Forms

Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A simple, rapid, precise, and reliable reverse phase HPLC method was developed for the separation and estimation of three drugs glimepiride, pioglitazone and metformin in...

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Main Authors: Gadapa Nirupa, Upendra M. Tripathi
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:Journal of Chemistry
Online Access:http://dx.doi.org/10.1155/2013/726235
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author Gadapa Nirupa
Upendra M. Tripathi
author_facet Gadapa Nirupa
Upendra M. Tripathi
author_sort Gadapa Nirupa
collection DOAJ
description Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A simple, rapid, precise, and reliable reverse phase HPLC method was developed for the separation and estimation of three drugs glimepiride, pioglitazone and metformin in bulk drug mix and pharmaceutical dosage forms. The estimation was carried out using Inertsil ODS-3V (250 mm × 4.6 mm, 5 μm) column; mobile phase consisting of acetonitrile, tetrahydrofuran, and buffer at pH 5; the flow rate of 1.7 mL/min and ultraviolet detection at 228 nm. All the three drugs were properly resolved having run time of 5 minutes, 3.9 minutes and 1.3 minutes for glimepiride, pioglitazone, and metformin, respectively. The method was validated as a final verification of method development with respect to precision, linearity, accuracy, ruggedness, and robustness. The validated method was successfully applied to the commercially available pharmaceutical dosage form, yielding very good and reproducible result.
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spelling doaj-art-6417b3bed90043b9b4353e59295876a72025-02-03T05:58:35ZengWileyJournal of Chemistry2090-90632090-90712013-01-01201310.1155/2013/726235726235RP-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Three Drugs: Glimepiride, Pioglitazone, and Metformin and Its Pharmaceutical Dosage FormsGadapa Nirupa0Upendra M. Tripathi1Department of Chemistry, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad 500085, AP, India Startech Labs Pvt. Ltd., 2nd Floor, SMR Chambers, H. Number: 1-58/7 Madinaguda, Hyderabad 500050, AP, India Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A simple, rapid, precise, and reliable reverse phase HPLC method was developed for the separation and estimation of three drugs glimepiride, pioglitazone and metformin in bulk drug mix and pharmaceutical dosage forms. The estimation was carried out using Inertsil ODS-3V (250 mm × 4.6 mm, 5 μm) column; mobile phase consisting of acetonitrile, tetrahydrofuran, and buffer at pH 5; the flow rate of 1.7 mL/min and ultraviolet detection at 228 nm. All the three drugs were properly resolved having run time of 5 minutes, 3.9 minutes and 1.3 minutes for glimepiride, pioglitazone, and metformin, respectively. The method was validated as a final verification of method development with respect to precision, linearity, accuracy, ruggedness, and robustness. The validated method was successfully applied to the commercially available pharmaceutical dosage form, yielding very good and reproducible result.http://dx.doi.org/10.1155/2013/726235
spellingShingle Gadapa Nirupa
Upendra M. Tripathi
RP-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Three Drugs: Glimepiride, Pioglitazone, and Metformin and Its Pharmaceutical Dosage Forms
Journal of Chemistry
title RP-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Three Drugs: Glimepiride, Pioglitazone, and Metformin and Its Pharmaceutical Dosage Forms
title_full RP-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Three Drugs: Glimepiride, Pioglitazone, and Metformin and Its Pharmaceutical Dosage Forms
title_fullStr RP-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Three Drugs: Glimepiride, Pioglitazone, and Metformin and Its Pharmaceutical Dosage Forms
title_full_unstemmed RP-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Three Drugs: Glimepiride, Pioglitazone, and Metformin and Its Pharmaceutical Dosage Forms
title_short RP-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Three Drugs: Glimepiride, Pioglitazone, and Metformin and Its Pharmaceutical Dosage Forms
title_sort rp hplc analytical method development and validation for simultaneous estimation of three drugs glimepiride pioglitazone and metformin and its pharmaceutical dosage forms
url http://dx.doi.org/10.1155/2013/726235
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AT upendramtripathi rphplcanalyticalmethoddevelopmentandvalidationforsimultaneousestimationofthreedrugsglimepiridepioglitazoneandmetforminanditspharmaceuticaldosageforms