Analytical Method Validation of EVT201 and Metabolites (Ro461927 and Ro 18-5528) in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry

Abstract

A highly sensitive and accurate liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been created and validated for measuring the levels EVT201 and its two metabolites, Ro46-1927 and Ro18-5528, in human plasma. This method was then used to analyze plasma samples from healthy Chinese individuals had taken EVT201 capsules orally, aiming to study the drug's behavior in the body over time (pharmacokinetics). The inter precision was within 75.86%, 98.13%, 98.39%, for EVT201 and 81.11%, 92.18%, 92.42% for Ro46-1927 and 138.39% and 141.58%, for Ro18-5528. The LC-MS/MS method proved to be reliable and precise, making it suitable for investigating EVT201's pharmacokinetics. By applying the validated analytical method, the concentrations EVT201 and its metabolites in human plasma were determined. These data were undergone statistical analysis to assess how EVT201 was processed in the human body following oral administration. In summary, the study employed liquid chromatography-tandem mass spectrometry (LC-MS/MS) to develop and validate an analytical method for quantifying EVT201 and its metabolites in human plasma, ultimately facilitating the evaluation of EVT201's pharmacokinetics in humans.