Development and Validation of RP-HPLC Method for Estimation of Lurasidone and its impurities Lurasidone 1 and Lurasidone 8

Abstract

Objective: The aim of the present work is the development of new, sensitive, specific, and accurate high-performance liquid chromatographic method for the Estimation of Lurasidone and its Impurities Lurasidone 1 and Lurasidone 8. Methods: The chromatographic separation of drug and its impurities was achieved using Inertsil ODS C18 column (150mm x 4.6mm, 5μm) with mobile phase consisted of mobile phase-A 0.05M Potassium Dihydrogen Phosphate buffer (pH- 4.0, adjusted with 1% Orthophosphoric acid) and mobile phase-B Acetonitrile in the ratio of 60:40 % v/v at a flow rate of 1.0 ml/min with ultraviolet detection at 230 nm. Results: Lurasidone and its Impurities Lurasidone 1 and Lurasidone 8 were successfully eluted at the retention time of 6.022, 5.024 and 10.456 min respectively, with good resolution. The described method was linear over a concentration range of 160-1200 μg/ml for Lurasidone, 1.6-12 μg/ml for Lurasidone 1 and Lurasidone 8. The % recoveries of Lurasidone was found to be 100.565% - 101.061%. The method was validated according to the international conference on harmonization guidelines. The validation results showed good precision, accuracy, linearity, specificity, sensitivity, and robustness. Conclusion: Successful separation and Estimation of Lurasidone and its Impurities Lurasidone 1 and Lurasidone 8 were achieved by the proposed method. The developed method can be applied for the routine analysis of Lurasidone and its impurities in pharmaceutical formulations.