Development and Validation of a Rp- HPLC Method for Simultaneous Estimation of Pioglitazone and Metformin in Bulk and Tablet Dosage Form

Abstract

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of pioglitazone and metformin in bulk and tablet dosage form. Chromatographic analysis was performed on a C 18 column (250x 4.6 mm, 5µm) with a mixture of Methanol:Phosphate buffer in in the ratio 68:32 as mobile phase, at a flow rate of 1.0 mL min -1 . UV detection was performed at 260 nm. The method was validated for accuracy,precision,specificity,linearity, and sensitivity. The retention times of pioglitazone and metformin were 7.24±0.051 and 2.54±0.038 min respectively. Calibration plots were linear over the concentration ranges 10-35 µg mL -1 and 15-40 µg mL -1 for pioiglitazone and metformin respectively. The Limit of detection was 0.382 and 0.131 µg/ml and the quantification limit was 1.27 µg/ml and 0.436 µg/ml for metformin and pioglitazone respectively. The accuracy of the proposed method was determined by recovery studies and found to be 98.65% to 98.90%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis of determination of rosiglitazone and metformin in bulk and tablet dosage form.