A validated stability-indicating high-performance liquid chromatographic method for the simultaneous quantification of pioglitazone and glimepridein pharmaceutical dosage form

Abstract

A simple, selective and precise Stability indicating RP-HPLC method was developed for the simultaneous estimation of Pioglitazone and Glimepiridein Pharmaceutical Dosage Forms. The chromatographic separation of the selected two drugs was achieved on a reverse phase ZORBAX Eclipse Plus C18,150 x 4.6 mm, 5µm usingacetonitrile: ethanol: buffer (20:30:50v/v/v) with a flow rate of 1.0 ml/min with injection volume 10 µL and the detection was carried out at 287 nm. The retention time of Pioglitazone and Glimepiride were found to be 3.8 and 5.4 min respectively. The drug products were subjected to stress conditions of acidic, alkaline, neutral, oxidation, UV and Thermal conditions. The degradation products were well resolved from Pioglitazone and Glimepiridepeaks, thus indicating the stabilityindicating nature of the method. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range of 15 – 90 µg/mlfor Pioglitazone, 1 -6µg/ml for Glimepiride. The developed method was successfully validated in accordance to ICH guidelines. Hence, this method can be conveniently adopted for the routine analysis in quality control laboratories.