Title:A Novel LC-MS Method for the Determination of Abiraterone in Rat Plasma
and its Application to Pharmacokinetic Studies
Volume: 18
Issue: 6
Author(s): Linzhi Dai, Pei Lv, Yun He, Xiaoli Wang, Lili Chen*Jing Dai*
Affiliation:
- Analytical Research Department, Chengdu Hyperway
Pharmaceuticals Co., Ltd., Chengdu, China
- School of Pharmacy, Chengdu Medical College, Chengdu, China
Keywords:
Bioanalytical method, LC-MS, abiraterone, method validation, rat plasma, pharmacokinetics.
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.
Methods: 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.