Contemporary HPLC-UV reverse phase method development and validation of anti-psychotic drug Lumateperone Tosylate, followed by forced degradation studies

Abstract

Background and Objective: Lumateperone an atypical anti-psychotic drug, approved for treatment of schizophrenia and bipolar depression. The present study is aimed for the development and validation of RP-HPLC method, the detection of Lumateperone followed by forced degradation studies.

Materials and Methods: Lumateperone is separated on a Kromasil C18, 150x 4.6mm, 5µm, 180Ao column using an isocratic mobile phase consisting of 0.01N potassium dihydrogen ortho phosphate and acetonitrile in the ratio of 60:40 at 30°C. The chromatographic detection was done using UV-VIS spectrophotometer at 245.0 nm. The developed method was validated for accuracy, precision, selectivity, linearity, solution stability, LOD and LOQ as per ICH guidelines.

Results: The method precision was found to be 99.78% with an RSD of 0.68%. The established LOD and LOQ are 0.22 and 0.66 µg/mL respectively. Oxidation of drug with 20% hydrogen peroxide (H2O2), acid degradation with 2N hydrochloric acid, alkali degradation using 2N sodium hydroxide, dry heat degradation, neutral degradation, and photo stability studies were evaluated as part of degradation studies with %recovery more than 94.4%.

Conclusion: This study was out with an explicit, clear and precise method and validated for all the parameters as per ICH guidelines with a high percentage recovery under various conditions of degradation