LC–MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column

Author:

Pursley Janice1,Shen Jim X1,Schuster Alan1,Dang Oanh T2,Lehman Jim2,Buonarati Michael H2,Song Yan1,Aubry Anne-Francoise1,Arnold Mark E1

Affiliation:

1. Bristol-Myers Squibb, Route 206 Province Line Road, Lawrenceville, NJ 08543, USA

2. Intertek Pharmaceutical Services, 1100 Windfield Way, El Dorado Hills, CA 95762, USA

Abstract

Background: apixaban (BMS-562247) (Eliquis®) is a novel, orally active, selective, direct, reversible inhibitor of the coagulation factor Xa (FXa). A sensitive and reliable method was developed and validated for the measurement of apixaban (BMS-562247) and its major circulating metabolite (BMS-730823) in human citrated plasma for use in clinical testing. Methodology/results: A 0.100 ml portion of citrated plasma sample was extracted and analyzed by LC–MS/MS. Run times were approximately 3 min. The lower limit of quantification (LLOQ) was 1.00 ng/ml for BMS-562247 and 5.00 ng/ml for BMS-730823. Intra- and inter-assay precision values for replicate QC control samples were within ≤5.36% for both analytes (≤7.52% at the LLOQ). The accuracy for both analytes was within ±9.00%. Conclusion: The method was demonstrated to be sensitive, selective and robust, and was successfully used to support clinical studies.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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