ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LUMATEPERONE TOSYLATE API BY UV SPECTROPHOTOMETRY

Lumateperone Tosylate is the Non-Pharmacopeial Anti-Psychotic drug which is used for the treatment of schizophrenia.A simple, precise, and cost effective UV-Spectrophotometric method was developed and validated for the estimation of Lumateperone Tosylate API.The absorbance and spectral measurements were done on a double-beam Labindia UV-Visible spectrophotometer with software UV Win.1cm quartz cells at wavelength 250 nm and solvent system used is Methanol: Dimethyl Sulphoxide in the ratio of 70:30.The method is developed and validated for linearity, precision, robustness, LOD, LOQ.Validation was carried out as per ICH Q2(R1) guidelines.