Applying the Quality by Design (CCD) technique for Simultaneous estimation of Metformin and Remogliflozin in bulk and pharmaceutical dosage form by HPTLC method

Abstract

The present study examines simultaneous multiple response optimization using Derringer’s desirability function for the development of an HPTLC method to detect Metformin and Remogliflozin in pharmaceutical dosage form. Central composite design (CCD) was used to optimize the chromatographic conditions for HPTLC. The independent variables used for the optimization were the methanol content in the mobile phase, wavelength and the chamber saturation time. HPTLC separation was performed on aluminium plates pre-coated with silica gel 60 F254 as the stationary phase using  methanol: ethyl acetate: acetic acid (7:2.5:0.5 % v/v/v) as the mobile phase. Quantification was achieved based on a densitometric analysis of Metformin and Remogliflozin over the concentration range of 40-65 µg/mL and 4.0-6.5 µg/mL, respectively, at 245 nm. The method yielded compact and well-resolved bands at Rf of 0.24 ± 0.04 and 0.48 ± 0.03 for Metformin and Remogliflozin, respectively. The linear regression analysis for the calibration plots produced r² = 0.9997 and r² = 0.9996 for Metformin and Remogliflozin respectively. The precision, accuracy, ruggedness, specificity, limit of detection and limit of quantitation of the method were validated according to the ICH guidelines. The factors evaluated in the validation parameters test were determined to have an insignificant effect on the selected responses. The results indicate that the method is suitable for the routine quality control testing of marketed tablet formulations.