Development and validation of LC-MS/MS method for determination of plasma apixaban

• Autorzy: Dzudovic Jelena , Crevar Sakac Milkica , Antunovic Marko , Repic Aleksandra , Obradovic Slobodan , Djordjevic Snezana , Savic Jelena , Dzudovic Boris

Identyfikatory

DOI

10.1556/1326.2021.00948

• Języki publikacji: EN

Abstrakty

EN

Oral anticoagulants are a group of drugs used for the prevention and treatment of venous thrombosis and venous thromboembolism. For the last ten years, direct oral anticoagulants (DOAC) have been available and are equally effective, but significantly safer than vitamin K antagonists. In the case of an overdose, their most important side effect is still bleeding. Due to their widespread use, as well as increased toxicological importance there is a need to develop an analytical method for the determination of DOAC in biological material. The aim of this paper was to establish a method for the quantification of apixaban as one of the representatives of DOAC. The methodology of the study included the measurement of apixaban in the plasma of patients treated in the intensive care unit. Plasma apixaban concentrations were determined by LC-MS/MS technique using carbamazepine as an internal standard. Obtained validation parameters indicate that the introduced method is sensitive, reliable, precise and accurate. Using this method, apixaban can be quickly and easily detected and quantified in plasma in patients who are suspected of overdosing with this drug.

Słowa kluczowe

EN

anticoagulants; DOAC; apixaban; LC-MS/MS

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2022
• Tom: Vol. 34, no. 3
• Strony: 332--337
• Opis fizyczny: Bibliogr. 24 poz., rys., tab., wykr.

Twórcy

autor

Dzudovic Jelena

• National Poison Control Center, Military Medical Academy, Belgrade, Serbia

autor

Crevar Sakac Milkica

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia

• https://orcid.org/0000-0002-6947-4824

autor

Antunovic Marko

• National Poison Control Center, Military Medical Academy, Belgrade, Serbia

autor

Repic Aleksandra

• Serbian Institute for Occupational Health “Dr Dragomir Karajovic”, Belgrade, Serbia

autor

Obradovic Slobodan

• Clinic for Cardiology, Military Medical Academy, Belgrade, Serbia

autor

Djordjevic Snezana

• Medical Faculty Military Medical Academy, University of Defense, Belgrade, Serbia

autor

Savic Jelena

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia

autor

Dzudovic Boris

• Clinic for Emergency Internal Medicine, Military Medical Academy, Belgrade, Serbia

Bibliografia

• 1. Luettgen, J.M.; Knabb, R.M.; He, K.; Pinto, D.J.; Rendina, A.R. J. Enzyme Inhib. Med. Chem. 2011, 26(4), 514–26.
• 2. Jiang, X.; Crain, E.J.; Luettgen, J.M.; Schumacher, W.A.; Wong, P.C. Thromb. Haemost. 2009, 101(4), 780–2.
• 3. Eliquis (Apixaban) Prescribing Information. Princeton, NJ and New York, NY: Bristol-Myers Squibb and Pfizer; 2015.
• 4. Frost, C.; Yu, Z.; Nepal, S.; Bragat, A.; Moore, K.; Shenker, A.; et al. J. Clin. Pharmacol. 2008, 48, 1132.
• 5. Wang, L.; Zhang, D.; Raghavan, N.; Yao, M.; Ma, L.; Frost, C.E.; et al. Drug Metab. Dispos. 2010, 38(3), 448–58.
• 6. Raghavan, N.; Frost, C.E.; Yu, Z.; He, K.; Zhang, H.; Humphreys, W.G.; et al. Drug Metab. Dispos. 2009, 37(1), 74–81.
• 7. Wang, X.; Mondal, S.; Wang, J.; Tirucherai, G.; Zhang, D.; Boyd, R.A.; et al. Am. J. Cardiovasc. Drugs 2014, 14(2), 147–54.
• 8. Nutescu, E.A.; Burnett, A.; Fanikos, J.; Spinler, S.; Wittkowsky, A. J. Thromb. Thrombolysis 2016, 41, 15–31.
• 9. Frost, C.E.; Byon, W.; Song, Y.; Wang, J.; Schuster, A.E.; Boyd, R.A.; et al. Br. J. Clin. Pharmacol. 2015, 79(5), 838–46.
• 10. Baglin, T.; et al., 2012, 2013; Cuker et al, 2014; Adcock & Gosselin. 2015.
• 11. Delavenne, X.; Mismetti, P.; Basset, T. J. Pharmaceut. Biomed. 2013, 150–3.
• 12. Lindahl, S.; Dyrkorn, R.; Spigset, O.; Hegstad, S. Ther. Drug Monit. 2018, 40, 369–76.
• 13. Țilea, I.; Popa, D.S.; Xantus, T.S.; et al. Revista Română de Medicină de Laborator 2015, 23, 115–25.
• 14. Baig, M.L.A.; Ali, S.A. J. Appl. Pharm. Sci. 2017, 7, 44–52.
• 15. Jeong, H.C.; Kim, T.E.; Shin, K.H. Trans. Clin. Pharmacol. 2019, 27, 33–41.
• 16. Derogis, P.B.M.; Sanches, L.R.; de Aranda, V.F.; Colombini, M.P.; Mangueira, C.L.P.; Katz, M.; et al. PLoS ONE 2017, 12; doi: 10.1371/journal.pone.0171272.
• 17. Guideline on validation of bioanalytical methods EMA. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf (Accessed Dec 16, 2014).
• 18. Guideline on validation of bioanalytical methods ICH. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M10/M10EWG_Step2_DraftGuideline_2019_0226.pdf.
• 19. Granger, C.B.; Alexander, J.H.; McMurray, J.J.; et al. N. Engl. J. Med. 2011, 365, 981–92.
• 20. Agnelli, G.; Buller, H.R.; Cohen, A.; et al. N. Engl. J. Med. 2013, 369, 799–808.
• 21. Barton, J.; Wong, A.; Graudins, A. 2016, 54(09), 871–3.
• 22. Leikin, S.M.; Patel, H.; Welker, K.L.; Leikin, J.B. Am J. Emerg. Med. 2017, 35(05), 801.e5–6.
• 23. Heo, Y.A. Drugs 2018, 78(10), 1049–55.
• 24. Guadarrama, D.S.; DeMarinis, S.M.; Sweeney, J.D. Blood Coagul. Fibrinolysis 2018, 29(2), 231–5.