A highly sensitive LC-MS/MS method to determine novel Bruton's tyrosine kinase inhibitor spebrutinib: application to metabolic stability evaluation.

ABSTRACT: Spebrutinib (SBT) is a Bruton's tyrosine kinase inhibitor. SBT is currently in phase II and phase I clinical trials for the management of rheumatoid arthritis and chronic lymphocytic leukaemia, respectively. We developed and validated a liquid chromatography tandem mass spectrometry analytical method to quantify SBT and investigate its metabolic stability. SBT and the naquotinib as internal standard were isocratically eluted on a C18 column. The linearity of the developed method is 5-500 ng ml^-1 (r² ≥ 0.9999) in the human liver microsomes (HLMs) matrix. Good sensitivity was approved by the very low limit of detection (0.39 ng ml^-1). Inter- and intra-assay accuracy values of -1.41 to 12.44 and precision values of 0.71% to 4.78%, were obtained. SBT was

SUBMITTER: Abdelhameed AS 

PROVIDER: S-EPMC6599791 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature