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Development and validation of a stability-indicatingHPLCmethod for quantitative analysis of antipsychotic drug and its related impurities

M.Balaji, K.M.Ch.AppaRao, K.Ramakrishna, V.Srinivasarao

A novel stability indicating liquid chromatographic method has been developed for the quantification of antipsychotic drug lurasidonealong with three impurities and validated as per ICH guidelines. The impurities were separated byRP-18 150x4.6mm, 5µm with a gradient mixture of mobile phase A containing 0.1%orthophosphoric acid and acetonitrile used asmobile phase B at 30ºC and detected at 205nm with a flow rate 1ml/min. The resolution between lurasidone and three impurities is found to be greater than 2.0. The drug was subjected to stress conditions of acid, base hydrolysis, oxidation, photolysis and thermal degradation. Considerable degradation was found to occur in base and oxidative stress conditions. The method was validated with respect to linearity, accuracy, precision and robustness. This method is capable to detect the impurities of lurasidone at a level of 0.0011% with respect to test concentration of 2.8mg/ml.