Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms

Abstract

The present work reports an ultra-performance liquid chromatography (RP-UPLC) method for the quantitative determination of pioglitazone HCl (PGZ) in pharmaceutical dosage form. The chromatographic separation was performed on C18, BEH (50 mm x 2.1 mm, 1.7 µm) column using isocratic elution. The optimized mobile phase consists of phosphate buffer (pH:6) as a solvent-A and 55:45 v/v mixture of acetonitrile as solvent-B. Flow rate was 0.4 ml/min with UV detection at (λmax) 225 nm and the injection volume was set at 2 µL with retention time 1 min. The developed RP-UPLC method was validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, accuracy, linearity.