Development of validated analytical method for estimation of Metformin and Pioglitazone in pharmaceutical dosage form

Abstract

A RP-HPLC method was developed using Comosil RP-C18 (4.6 x 150mm, 5m) as stationary phase with younglin (S.K.) isocratic system UV detector in a gradient mode with mobile phase comprising of Acetonitrie : Pott. Dihydrogen Phosphate (adjusted pH-2.5 using OPA). 0.7ml/min flow rate and monitoring of effluent were done at 254.0 nm for MET (Metformin) and PIOG(Pioglitazone) estimation in combined dosage form.2.1 min for MET and 7.53 min for PIOG retention times were found. The dynamic range of linearity 50- 250 g/mL for MET and 3- 15 g/mL for PIOG were exhibited for the assay. The linear calibration curves were found over the entire range linearity (r ² = 0.996 for MET and r ² = 0.995 for PIOG) and 99.81 % for MET and 99.33 % for PIOG mean % recovery was found with % RSD was NMT 2 for both estimations which fully agrees by system suitability in good agreement with labeled claimed of formulation. The % RSD for Intra and Inter-Day Precision was NMT than 2 for both drugs. The developed method was accurate, precise, rugged and linear as per ICH guidelines