LC–MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column-Reference-Cited by-同舟云学术

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

Published:2014-08 Issue:15 Volume:6 Page:2071-2082
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

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

Link

http://www.future-science.com/doi/pdf/10.4155/bio.14.66

Reference23 articles.

1. An overview of various validated HPLC and LC-MS/MS methods for quantitation of drugs in bile: challenges and considerations

2. LC–MS/MS bioanalytical challenge: ultra-high sensitivity assays

3. Recent advances in high-throughput quantitative bioanalysis by LC–MS/MS

4. Discovery of 1-(4-Methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro- 1H-pyrazolo[3,4-c]pyridine-3-carboxamide (Apixaban, BMS-562247), a Highly Potent, Selective, Efficacious, and Orally Bioavailable Inhibitor of Blood Coagulation Factor Xa

5. Apixaban: A New Player in the Anticoagulant Class

Cited by 47 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Dried plasma spot as an innovative approach to therapeutic drug monitoring of apixaban: Development and validation of a novel liquid chromatography‐tandem mass spectrometry method;Journal of Mass Spectrometry;2024-08-26

2. A rapid and sensitive analytical methodology for the simultaneous biomonitoring of two direct oral anticoagulant drugs and their major metabolites in thromboembolic disordered patients samples for clinical evaluations;Journal of Chromatography A;2024-02

3. Understanding the Stress Testing Characteristics of Apixaban, Structural Elucidation of a Novel Degradation Impurity, and Stability-Indicating Method Development for Quantification of Related Substances;Journal of AOAC International;2023-09-12

4. Using the AQbD Approach, Development and Validation of a Simple, Rapid Stability Indicating Chromatographic Method for Quantification of Related Impurities of Apixaban;Journal of Chromatographic Science;2023-08-17

5. Green fitted second derivative synchronous spectrofluorometric method for simultaneous determination of remdesivir and apixaban at Nano gram scale in the spiked human plasma;Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy;2023-04