LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column
Pursley, J.; Shen, J.X.; Schuster, A.; Dang, O.T.; Lehman, J.; Buonarati, M.H.; Song, Y.; Aubry, A.-F.; Arnold, M.E.
Bioanalysis 6(15): 2071-2082
ISSN/ISBN: 1757-6199 PMID: 25322783 DOI: 10.4155/bio.14.66
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. 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%. The method was demonstrated to be sensitive, selective and robust, and was successfully used to support clinical studies.