Article

Development and Validation of Simultaneous Chromatographic method for Estimation of Metformin Hcl, Pioglitazone Hcl and Glipizide in a CombinedDosage Form by RP- HPLC
M. Aruna Devi , Madhukar. A*, Lingeswara Rao. P, CH. Naveen Kumar, B. Bahugunachary, L. Rajesh Patro

Details

Author

M. Aruna Devi

ISSN

2319-5622

DOI

4

Published on

Nov 21, 2013

Abstract

A simple, rapid, and precise reversed-phase high-performance liquid chromatographic method for simultaneous analysis of Metformin Hcl, Pioglitazone Hcl, and Glipizide in a tablet dosage form has been developed and validated. Chromatography was performed on an Ine rtsil C18, 250 X 4.6mm, 5µ column with 40:60 (v/v) 10 mM potassium dihydrogen phosphate buffer: methanol as mobile phase at a flow rate of 1.2 ml/min. UV detection at 240nm; Metformin Hcl, Pioglitazone Hcl, and Glipizide were eluted with retention times of 1.766, 5.316, and 9 .550min, respectively. The method was validated in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 5-100μg/ml for Metformin Hcl, Pioglitazone Hcl, and Glipizide. The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of the three drugs in tablets. Statistical analysis proves that the method is suitable for the analysis of Metformin Hcl, Pioglitazone Hcl and Glipizide as a bulk drug and in pharmaceutical formulation without any interference from the excipients. It may be extended to study the degradation kinetics of three drugs and also for its estimation in plasma and other biological fluids.

Keywords

Metformin Hcl, Pioglitazone Hcl and Glipizide, RP-HPLC, Validation, Combined Dosage Forms

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