Analytical Method Development and Validation for The Estimation of Pioglitazone Hydrochloride in Bulk and Formulation by UV-Spectrophotometry

The present work deals with the development of reliable method for the estimation of pioglitazone hydrochloride by using UV spectroscopy. The pioglitazone hydrochloride showed absorption maxima at wavelength 268nm respectively. The linearity range for pioglitazone hydrochloride was in the range of 10-50μg/ml with correlation coefficient of 0.999. The precision was carried out for pioglitazone hydrochloride and value was found to be less than 2. The proposed method’s results were found satisfactory and are suitable for determination of pioglitazone hydrochloride for routine quality control of drug in bulk and formulation. This method is validated according to ICH guidelines Q2R1. Keywords: Pioglitazone hydrochloride, ICH guidelines, validation, method development.