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

Author(s): Ali Saad Abdo Alwesabi, K.Mukkanti, K.Chandra Shekar

A simple, sensitive, rapid low cost, accurate and precise reverse phase high performance liquid chromatographicmethod was developed for the estimation ofMetformin HCl (Mt) and Pioglitazone HCl (Pg) in pure and in pharmaceutical dosage forms.AHypersilBDSC18 column (250x4.6mm, 5ì) was usedwith amobile phase containing amixture ofAcetonitrile (C2H3N,41.05g mol-1, 99.8 - 100%) and 0.01M Sodium dihydrogen phosphate buffer (NaH2PO4, 119.98 g/mol) in the ratio of 60 : 40(v/v) respectively. The flow ratewas 1ml/min and effluentsweremonitored at 228 nmand eluted at 2.280 min (Mt) and 3.960min (Pg).Calibration curvewas plottedwith a range from 20-120 ìg/ml for Mt and 0.6 - 3.6 ìg/ml for Pt. The assaywas validated for the parameters like accuracy, precision and system suitability parameters. The proposed method can be useful in the routine analysis for the determination on metformin and pioglitazone in pharmaceutical dosage forms.

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