High-performance thin-layer chromatographic determination of itopride hydrochloride in its pharmaceutical preparation and in the bulk drug

Abstract

A normal-phase high-performance thin-layer chromatographic (HPTLC) method has been established for quantitative estimation of itopride hydrochloride, a gastroprokinetic agent, in its pharmaceutical formulation and in the bulk drug substance. Analysis was performed on silica gel 60F 254 TLC plates with methanol-ethyl acetate-toluene-triethylamine, 1.0 + 2.5 + 6.0 + 0.5 ( v/v ), as mobile phase. Detection and quantitation were performed densitometrically at 1 = 230 nm. Diltiazem hydrochloride was used as the internal standard. Response to itopride hydrochloride was found to be linear in the concentration range 50.00 to 2000.00 μg mL −1 . The method was validated for accuracy and precision. Accuracy was checked by conducting recovery studies; the average recovery was found to be 99.27%. The method is simple, rapid, and precise and can be used for routine quality control.