Abstract

NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ANALYSIS OF LURASIDONE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

P. Ravisankar*, G. Rajyalakshmi, Ch. Deva Dasu, P. Srinivasa Babu, P.Venkateswar Reddy

Abstract

A convenient, simple, specific, accurate, precise, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Lurasidone HCl in pharmaceutical tablet dosage forms. RP-HPLC method was developed by using Welchrom C18Column (4.6 X 250mm, 5μm), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 10mM Phosphate buffer (pH-3.0, adjusted with triethylamine): acetonitrile (50:50v/v). The flow rate was set to 1.0 mL.min-1 with the responses measured at 235nm using Shimadzu SPD-20A Prominence UV-Vis detector. The retention time of Lurasidone HCl was found to be 4.333 minutes. Linearity was established for Lurasidone HCl in the range of 10-50μg.mL-1with correlation coefficient 0.9999.The LOD and the LOQ were found to be0.0653μg.mL-1and 0.1980μg.mL-1respectively. The amount of Lurasidone HCl present in the formulation was found to be 99.90 %. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of Lurasidone HCl in pharmaceutical tablet dosage form.

Keywords: Lurasidone HCl, Isocratic RP-HPLC, Method Validation, ICH guidelines.