Development of a validated high-performance liquid chromatographic method for the determination of Lurasidone in pharmaceuticals

Abstract

A new, rapid and simple HPLC method for determination of Lurasidone in its tablets has been developed and validated. Lurasidone and internal standard (Chlorpromazine) was separated on a Zorbax XDB C8 column (4.6 x 50 mm, 3.5 μm particle size) set at 40°C and quantified by ultraviolet detection at 230 nm. The mobile phase was phosphate buffer (pH:3, 20 mM): acetonitrile: methanol (55:10:35, v/v/v) with a flow rate of 1.2 mL/min. Retention times of Chlorpromazine and Lurasidone was 4.73 and 6.89 minutes, respectively. The method was found linear over the concentration range of 0.5-50 μg/mL Lurasidone. Limit of detection and quantification values for Lurasidone was 0.1295 and 0.4317 μg/mL, respectively. The intra- and inter day precisions were less than 2% and the mean recoveries were 100.32%, which indicated that the method was precise and accurate. All other validation parameters were found within acceptable limits. The validated method has been successfully applied for determination of Lurasidone in its tablets. Keywords: