A Novel LC-MS Method for the Determination of Abiraterone in Rat Plasma and its Application to Pharmacokinetic Studies

Abstract

Background: High-Performance Liquid Chromatography (HPLC)-Ultraviolet (UV) and Liquid Chromatography (LC)-Mass Spectrometry (MS)/MS methods have been used to analyse abiraterone (ART); however, a single-quadrupole mass spectrometer with LC-MS systems has never been used to analyse ART. Objective: The study aimed to establish a novel, simple assay of quantitating ART in rat plasma through LC-MS. Method: The analytical procedure involved the extraction of ART and D4-ART (internal standard, IS) from rat plasma through simple protein precipitation. Chromatographic separation was achieved using an isocratic mobile phase (acetonitrile: 5 mM ammonium formate with 0.1% formic acid, 50:50 v/v) at a flow rate of 0.30 mL/min on a Waters XBridge® C18 column with a total run time of 5 min. LC-MS ion transitions monitored were 350.1 and 354.1 for ART and IS, respectively. The method was validated, and the results met acceptance criteria. Results: The lower limit of quantitation achieved was 1 ng/mL, and linearity was 1-8000 ng/mL. The intra- and inter-day precisions were 1.26%-14.20% and 5.49%-13.08%, respectively, in rat plasma. Conclusion: LC-MS offers a novel, specific, sensitive, and accurate method for quantifying ART and it was successfully applied to pharmacokinetic studies of ART in rats.