Have a personal or library account? Click to login
Rapid liquid chromatography tandem mass spectrometry determination of rivaroxaban levels in human plasma for therapeutic drug monitoring Cover

Rapid liquid chromatography tandem mass spectrometry determination of rivaroxaban levels in human plasma for therapeutic drug monitoring

Open Access
|Apr 2017

References

  1. 1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov; 3(11): e442. 2011-30.10.1371/journal.pmed.0030442166460117132052
  2. 2. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus warfarin in patients with atrium fibrillation. N Engl J Med. 2009 Sep;361(12):1139-51. DOI: 10.1056/NEJMoa090556110.1056/NEJMoa090556119717844
  3. 3. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrilation. N Engl J Med. 2011 Sep; 365(10):883-91. DOI: 10.1056/NEJMoa100963810.1056/NEJMoa100963821830957
  4. 4. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep; 365(11):981-92. DOI: 10.1056/NEJMoa110703910.1056/NEJMoa110703921870978
  5. 5. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov; 369(22):2093-104. DOI: 10.1056/ NEJMoa131090710.1056/NEJMoa131090724251359
  6. 6. Scridon A, Șerban RC. Laboratory monitoring - a turning point in the use of new oral anticoagulants. Ther Drug Monit. 2016 Feb; 38(1):12-21. DOI: 10.1097/ FTD.000000000000024710.1097/FTD.000000000000024726352868
  7. 7. Baglin T, Hillarp A, Tripodi A, Elalamy I, Buller H, Ageno W. Measuring oral direct inhibitors (ODIs) of thrombin and factor Xa: a recommendation from the subcommittee on control of anticoagulation of the scientific and standardisation committee of the international society on thrombosis and haemostasis. J Thromb Haemost. 2013 Jan;11:756-60. DOI: 10.1111/jth.1214910.1111/jth.1214923347120
  8. 8. Kuhn J, Gripp T, Flieder T, Dittrich M, Hendig D, Busse J, et al. UPLC-MRM mass spectrometry method for measurement of the coagulation inhibitors dabigatran and rivaroxaban in human plasma and its comparison with functional assays. PLoS ONE. 2015 Dec; 10(12):e0145478. DOI: 10.1371/journal.pone.014547810.1371/journal.pone.0145478468954626699714
  9. 9. Korostelev M, Bihan K, Ferreol L, Tissot N, Hulot JS, Funck-Brentano C, et al. Simultaneous determination of rivaroxaban and dabigatran levels in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal. 2014 Nov;100:230-5. DOI: 10.1016/j.jpba.2014.08.01110.1016/j.jpba.2014.08.01125173108
  10. 10. Cheng YH, Chen WC, Chang SY. Rapid determination of rivaroxaban in human urine and serum using colloidal palladium surface-assisted laser desorption/ ionization mass spectrometry. Rapid Commun Mass Spectrom. 2015 Nov; 29(21):1977-83. DOI: 10.1002/ rcm.730810.1002/rcm.730826443396
  11. 11. Rohde G. Determination of rivaroxaban - a novel, oral, direct Factor Xa inhibitor - in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Sep; 872(1-2):43-50. DOI: 10.1016/j. jchromb.2008.07.015
  12. 12. Schellings MW, Boonen K, Schmitz EM, Jonkers F, van den Heuvel DJ, Besselaar A, et al. Determination of dabigatran and rivaroxaban by ultra-performance liquid chromatography-tandem mass spectrometry and coagulation assays after major orthopaedic surgery. Thromb Res. 2016 Mar; 139:128-34. DOI: 10.1016/j. thromres.2016.01.012
  13. 13. Srinivas Reddy G, Prasad Reddy SLN, Shiva Kumar Reddy L. Development and validation of Hplc-Ms/Ms Method for Rivaroxaban quantitation in human plasma using solid phase extraction procedure. Orient J Chem. 2016 Dec; 32(2):1145-54. DOI: 10.13005/ojc/32024010.13005/ojc/320240
  14. 14. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Veterinary Medicine (CVM). Guidance for Industry. Bioanalytical Method Validation. 2013 Sep; available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf
  15. 15. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on bioanalytical method validation. 2011, Jul; available at http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
  16. 16. Stangier J, Stähle H, Rathgen K, Fuhr R. Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects. Clin Pharmacokinet. 2008 Jan; 47(1):47-59. DOI: 10.2165/00003088-200847010-0000510.2165/00003088-200847010-0000518076218
  17. 17. EINSTEIN-PE Investigators, Bűller HR, Prins MH, Lensin AW, Decousus H, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr; 366(14):1287-97. DOI: 10.1056/NEJMoa111357210.1056/NEJMoa111357222449293
  18. 18. Perzborn E, Roehrig S, Straub A, Kubitza D, Misselwitz F. The discovery and development of rivaroxaban, an oral direct factor Xa inhibitor. Nat Rev Drug Discov. 2011 Jan;10(1):61-75. DOI: 10.1038/nrd318510.1038/nrd318521164526
  19. 19. Gnoth MJ, Buetehorn U, Muenster U, Schwartz T, Sandmann S. In vitro and in vivo P-glycoprotein transport characteristics of rivaroxaban. J Pharmacol Exp Ther. 2011 Jul;338(1):372-80. DOI: 10.1124/ jpet.111.18024010.1124/jpet.111.18024021515813
  20. 20. Mueck W, Becka M, Kubitza D, Voith B, Zuehlsdorf M. Population model of the pharmacokinetics and pharmacodynamics of rivaroxaban-an oral, direct factor Xa inhibitor-in healthy subjects. Int J Clin Pharmacol Ther. 2007 Jun; 45(6):335-44. DOI: 10.5414/CPP4533510.5414/CPP4533517595891
  21. 21. Ten Cate H. New oral anticoagulants: discussion on monitoring and adherence should start now! Thromb J 2013 Jun; 11(1):8. DOI: 10.1186/1477-9560-11-8 10.1186/1477-9560-11-8371668523809888
DOI: https://doi.org/10.1515/rrlm-2017-0007 | Journal eISSN: 2284-5623 | Journal ISSN: 1841-6624
Language: English
Page range: 145 - 155
Submitted on: Nov 6, 2016
|
Accepted on: Jan 17, 2017
|
Published on: Apr 28, 2017
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2017 Andreea Varga, Răzvan Constantin Șerban, Daniela Lucia Muntean, Cristina Maria Tătar, Lenard Farczadi, Ioan Tilea, published by Romanian Association of Laboratory Medicine
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.