Development and validation of an LC-MS/MS method to measure the BRAF inhibitors dabrafenib and encorafenib quantitatively and four major metabolites semi-quantitatively in human plasma.

ABSTRACT: This article describes the development and validation of a liquid-chromatography coupled with tandem mass spectrometry (LC-MS/MS) assay for the simultaneous quantitation of the BRAF inhibitors dabrafenib and encorafenib, and semi-quantitation of their major metabolites (i.e., carboxy-dabrafenib, desmethyl-dabrafenib, hydroxy-dabrafenib, M42.5A) in human plasma. Analytes were extracted from human plasma by protein precipitation, followed by reversed phase high-performance liquid chromatography. Analyte detection was performed using tandem mass spectrometry with heated electrospray ionization operating in positive ion mode. The assay was validated in accordance with the current U.S. Food and Drug Administration Guidance on Bioanalytical Method Validation. Results showed that measurements wer

SUBMITTER: Myszkiewicz MF 

PROVIDER: S-EPMC10528671 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature