title: LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column.
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.
  
  
  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%.
  
  
  CONCLUSIONS
  The method was demonstrated to be sensitive, selective and robust, and was successfully used to support clinical studies.
authors.affiliation: Bristol-Myers Squibb, Route 206 Province Line Road, Lawrenceville, NJ 08543, USA.
authors.forename: Janice
authors.initials: J
authors.lastname: Pursley
authors.forename: Jim X
authors.initials: JX
authors.lastname: Shen
authors.forename: Alan
authors.initials: A
authors.lastname: Schuster
authors.forename: Oanh T
authors.initials: OT
authors.lastname: Dang
authors.forename: Jim
authors.initials: J
authors.lastname: Lehman
authors.forename: Michael H
authors.initials: MH
authors.lastname: Buonarati
authors.forename: Yan
authors.initials: Y
authors.lastname: Song
authors.forename: Anne-Francoise
authors.initials: AF
authors.lastname: Aubry
authors.forename: Mark E
authors.initials: ME
authors.lastname: Arnold
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D065427:Factor Xa Inhibitors / Q000097:blood; D006801:Humans; D011720:Pyrazoles / Q000097:blood*; D011728:Pyridones / Q000097:blood*; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban