Degradation Studies on Lurasidone Hydrochloride using Validated Reverse Phase HPLC and LC-MS/MS

Lurasidone hydrochloride is antipsychotic drug from benzisothiazole derivatives. Lurasidone shows low bioavailability at the brain tissue after oral administration. The drug is under investigation by several researchers to develop alternate delivery system to improve bioavailability. The stability of the drug molecule is of great significance in such alternate delivery system. To demonstrate the drug's stability, a reverse phase high performance liquid chromatography interfaced with a triple quadrupole mass spectrometer was created and verified. The developed method was found to be linear in the concentration range of 10 μg/mL to 50 μg/mL. The regression analysis gave a coefficient of determination (r2) value of 0.999. The limit of detection and limit of quantification was 0.091 and 0.275 μg/mL respectively. The approach is analysed for standard parameters of accuracy, percentage recovery, robustness, system suitability and inter day and intraday precision. Lurasidone hydrochloride was subjected to forced degradation under various conditions using acid, alkali, H2O2, distilled water, and Ultraviolet light. The degraded products were analyzed using LC-MS tuned for a mass range of 100 m/z to 550 m/z. Lurasidone was more liable to alkali hydrolysis. Fragmentation of Lurasidone gave m/z peaks at 109, 166, 220, and 317 and possible fragmentation pattern was also evaluated. The LC-MS analysis can be successfully used for evaluating stability and identifying drug intermediates.