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

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of rosiglitazone and metformin in bulk and tablet dosage form. Chromatographic analysis was performed on a C18 column (250x 4.6 mm, 5μm) with a mixture of Ammonium dihydrogen Phosphate buffer (pH 4.5): Acetonitrilein in the ratio 65:35 as mobile phase, at a flow rate of 1.0 mL min^-1. UV detection was performed at 230 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of rosiglitazone and metformin were 7.19pm0.044 and 5.57pm0.038 min, respectively. Calibration plots were linear over the concentration ranges 12–32 μg mL^-1 and 20–70 μg mL^-1for rosiglitazone and metformin, respectively. The Limit of detection was 1.100 and 0.712 μg mL^-1and the quantification limit was 3.66 μg mL^-1 and 2.41 μg mL^-1 for metformin and rosiglitazone, respectively. The accuracy of the proposed method was determined by recovery studies and found to be 97.72% to 100.46%. 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.