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Journal of Chemistry
Volume 2013, Article ID 726235, 8 pages
http://dx.doi.org/10.1155/2013/726235
Research Article

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

1Department of Chemistry, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad 500085, AP, India
2Startech Labs Pvt. Ltd., 2nd Floor, SMR Chambers, H. Number: 1-58/7 Madinaguda, Hyderabad 500050, AP, India

Received 11 February 2012; Accepted 2 May 2012

Academic Editor: Jun Zhang

Copyright © 2013 Gadapa Nirupa and Upendra M. Tripathi. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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.