Abstract

DEVELOPMENT AND VALIDATION OF PIOGLITAZONE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL FORMULATIONS BY RP-HPLC METHOD

Pramila T. Alka Agarwal* and Maya Sharma

Abstract

A simple, specific, quick, isocratic Reversed Phase High Performance Liquid Chromatographic method was developed and validated for the analysis of pioglitazone hydrochloride. RP HPLC method was developed on a Hypersil BDS, 5μ, 250 x 4.6mm, reversed-phase column. The mobile phase was 0.01M Potassium dihydrogen phosphate: acetonitrile, 40:60 (v/v) at a flow rate of 1.0 ml/min. and the elute was monitored at 225 nm. The retention time of the drug was found to be 4.726 min. The method was linear over the range of 80-320 μg/ml with a regression coefficient of 0.999 and validated with respect to accuracy, precision, linearity, and specificity, limit of detection and limit of quantization as per the guidelines of International Conference for Harmonization (ICH). This method can be used in the industries for determination of pioglitazone hydrochloride to analyze the quality of formulation without interference of the excipients.

Keywords: pioglitazone hydrochloride, RP-HPLC, validation, ICH.