DEVELOPMENT OF HPTLC METHOD FOR THE ESTIMATION OF PIOGLITAZONE AND ALOGLIPTIN IN SYNTHETIC MIXTURE

Abstract

A precise and accurate HPTLC method for simultaneous estimation of pioglitazone HCl (PIO) and alogliptin benzoate (ALO) in synthetic mixture has been developed. The stationary phase selected was Pre-coated TLC plates (silica gel G60 – F254 aluminium sheet) and the mobile phase selected was n-butanol : water : acetic acid (6 : 3 :1 V/V/V). The separated spots were densitometrically analyzed in absorbance mode at 270 nm. The Rf value of PIO and ALO were found to be 0.70 and 0.39, respectively. The calibration curve of PIO and ALO were plotted in the range of 400 – 1600 ng/band, which showed the linear correction coefficient (r2) 0.9971 for PIO and 0.998 for ALO, respectively. The stock solutions of both the drugs were subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photo degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their Rf values. Stressed samples were assayed using developed HPTLC method. The method was validated as per ICH guideline Q2 (R1) and applied successfully for determination of both drugs in synthetic mixture.