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

Author(s):

Linzhi Dai, Pei Lv, Yun He, Xiaoli Wang, Lili Chen* and Jing Dai*   Pages 1 - 8 ( 8 )

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.

Keywords:

Bioanalytical method, LC-MS, abiraterone, method validation, rat plasma, pharmacokinetics.

Affiliation:

School of Pharmacy, Chengdu Medical College, Chengdu, Analytical Research Department, Chengdu Hyperway Pharmaceuticals Co., Ltd., Chengdu, Dental Department, School of Preclinical Medicine, Chengdu University, Chengdu, Clinical School of Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, Analytical Research Department, Chengdu Hyperway Pharmaceuticals Co., Ltd., Chengdu, School of Pharmacy, Chengdu Medical College, Chengdu



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