ABSTRACT

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. Keywords: Lumateperone Tosylate API, Non-Pharmacopeial, Anti-Psychotic, UV, Validation, ICH Q2(R1)
Publication date: 01/10/2025

https://ijbpas.com/pdf/2025/October/MS_IJBPAS_2025_9447.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.10.9447