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Analytical method development and method validation of metformin hydrochloride and pioglitazone hydrochloride in bulk and their pharmaceutical dosage forms by RP-HPLC.

Ali Saad Abdo Alwesabi, K.Mukkanti, K.Chandra Shekar

A simple, sensitive, rapid, low cost, accurate and precise reverse phase high performance liquid chromatographic method was developed for the estimation ofMetformin HCl (Mt) and Pioglitazone HCl (Pg) in pure and in pharmaceutical dosage forms.AHypersil BDSC18 column (250x4.6mm, 5ì) was used with a mobile phase containing a mixture of Acetonitrile (C2H3N,41.05 g mol-1, 99.8 - 100%) and 0.01MSodiumdihydrogen phosphate solution (NaH2PO4, 119.98 gmol-1) in the ratio of 60 : 40(v/v) respectively. The flow rate was 1 ml/min and effluents were monitored at 228 nm and eluted at 2.280 min (Mt) and 3.960 min (Pg). Calibration curve was plottedwith a range from20-120 ìg/ml for Mt and 0.6 - 3.6 ìg/ml for Pt. The assay was validated for the parameters like accuracy, precision and system suitability parameters. The proposed method can be useful in the routine analysis for the determination onmetformin and pioglitazone in pharmaceutical dosage forms.