期刊
BIOANALYSIS
卷 6, 期 15, 页码 2071-2082出版社
FUTURE SCI LTD
DOI: 10.4155/bio.14.66
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资金
- Bristol-Myers Squibb
Background: apixaban (BMS-562247) (Eliquis((R))) 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.
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