Development and Validation for the Simultaneous Estimation of Pioglitazone Hydrochloride and Glimipride in Mixed Dosage Form by RP-HPLC Method

摘要

A simple, accurate, precise and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method has been developed, which can separate and quantitatively estimate Pioglitazone Hydrochloride and Glimipride in mixed dosage form. The chromatographic separation for Pioglitazone Hydrochloride and Glimipride was achieved with mobile phase containing acetonitrile and phosphate buffer P15 4 (70:30 % v/v), reverse phase Thermo scientific Hypersil BDS 5μ CIS 120A (250 X 4.60 mm i.d ) column in isocratic mode at room temperature and UV detection 232nm. The compounds were eluted at a flow rate of 1.2 ml/min. The retention times of Pioglitazone Hydrochloride and Glimipride were found to be 3.301min and 3.854min respectively. The above method was validated in terms of System suitability, linearity, accuracy, precision, Limit of Detection (LOD), Limit of Quantification (LOQ) in accordance with ICH guidelines. The method was rapid, simple, economical and suitable for routine quality control analysis.