Validated Spectrophotometric Methods For The Estimation of Lurasidone Hydrochloride in Bulk And Pharmaceutical Dosage Forms

Three new, simple and cost effective UV-Spectrophotometric methods were developed for the estimation of Lurasidone hydrochloride in bulk and pharmaceutical formulations. Lurasidone hydrochloride was estimated at 227 nm in UV-spectroscopic method (Method A), 237 nm in first order derivative spectroscopy (Method B) and scanned at 225.0 - 235.0 nm in Area under Curve method (Method C). Linearity range was found to be 5-30 μg/ml (Correlation coefficient r = 0.999in method A, r = 0.999 in method B and r = 0.999 in method C) in all the three methods. These methods were tested and validated for various parameters according to ICH guidelines. The proposed Methods were successfully applied for the determination of Lurasidone hydrochloride in pharmaceutical formulation (Tablets). The results of recovery were found to be 99.44-101.28 % for method A, -100.33- -101.46% for Method B, and for Method C % Recovery was found to be 99.83-100.76% which was within limits.(98-102%). Limit of Detection and Limit of Quantification were 0.2044, 0.6196 for method A, 0.6350, 1.9245 for method B and 0.0831, 0.2521 for method C. The results demonstrated that the procedure is accurate, precise and reproducible (% relative standard deviation <2%), while being simple, cheap and less time consuming and can be suitably applied for the estimation of Lurasidone hydrochloride in tablet dosage forms.