ABSTRACT:
A simple, specific and accurate stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of Glimepride, Pioglitazone hydrochloride and Metformin hydrochloride. An isocratic RP-HPLC was achieved on younglin HPLC system using Varian C18 (250 ? 4.6 mm i.d, 5 µm particle size) column with the mobile phase containing mixture of methanol: phosphate buffer (pH 4.0, adjusted with glacial acetic acid) (70: 30, v/v). The flow rate was 1.0ml/min and the eluent was monitored at 240nm. The retention times of Glimepride, Pioglitazone hydrochloride and Metformin hydrochloride were found to be 9.95, 7.12 and 2.66 min respectively. Linearity was established for Glimepride, Pioglitazone hydrochloride and Metformin hydrochloride in the range of 2-12 µg/ml, 5-30 µg/ml and 200-1200 µg/ml respectively. The percentage recoveries of Glimepride, Pioglitazone hydrochloride and Metformin hydrochloride were found to be in the range of 99.44±0.32, 99.36±0.16, 99.87%±0.7 and 99.89%±0.15 respectively. All the drugs were subjected to acid, alkali, neutral, oxidation and dry heat degradation. The degradation studies indicated, Glimepride and Pioglitazone hydrochloride showed degradation in acid, alkaline, H 2O2, dry heat and in neutral condition. The degradation products were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of Glimepride, Pioglitazone hydrochloride and Metformin hydrochloride in bulk drugs and formulations.