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Current Pharmaceutical Analysis

Author(s): Linzhi Dai, Pei Lv, Yun He, Xiaoli Wang, Lili Chen* and Jing Dai*

DOI: 10.2174/2213337208666210816112837

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

Page: [590 - 597] Pages: 8

  • * (Excluding Mailing and Handling)

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.

Graphical Abstract

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