DEVELOPMENT AND VALIDATION OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR ESTIMATION OF LURASIDONE HYDROCHLORIDE IN SYNTHETIC MIXTURE

Abstract

This research manuscript describes simple, sensitive, accurate, precise and repeatable reverse phase high performance liquid chromatography method for the determination of Lurasidone Hydrochloride in synthetic mixture. The sample was analyzed by reverse phase C₁₈ column (Phenomenex C₁₈, 250 mm × 4.6 mm, 5µ) as stationary phase; acetonitrile : methanol : water (45 : 40 : 15 , v/v/v) as a mobile phase at a flow rate of 1.0 ml/min. Quantification was achieved with Photo Diode Array detector at 230 nm. The retention time for Lurasidone Hydrochloride was found to be 3.906 min. The linearity for the drug was obtained in the concentration range of 4-32 µg/ml with mean accuracies 100.42 ± 1.69. The method was successfully applied to synthetic mixture because no chromatographic interferences from formulation excipients were found. The method retained its accuracy and precision when the standard addition technique was applied.