LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column.
| Autor: | Pursley J; Bristol-Myers Squibb, Route 206 Province Line Road, Lawrenceville, NJ 08543, USA., Shen JX, Schuster A, Dang OT, Lehman J, Buonarati MH, Song Y, Aubry AF, Arnold ME |
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| Jazyk: | angličtina |
| Zdroj: | Bioanalysis [Bioanalysis] 2014 Aug; Vol. 6 (15), pp. 2071-82. |
| DOI: | 10.4155/bio.14.66 |
| Abstrakt: | 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. |
| Databáze: | MEDLINE |
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