Abstract

Background: SARS-CoV-2 is considered one of the most widely spreaded viral infections globally. Expectation of second wave incidence of Corona virus 2019 is high. Direct inhibitors of factor Xa might be proposed as an adjuvant therapy for coagulation disorders associated with COVID-19.

Aim: Development of a bioanalytical assay for detection of rivaroxaban in human plasma and its pharmacokinetics application including bioavailability studies and monitoring of therapeutic levels to ensure its clinical outcomes as an adjuvant therapy in management of Corona virus 2019 disease.

Method: A protein precipitation technique was used for drug extraction from the plasma by using a mobile phase of 10 mM ammonium acetate pH4.7 and acetonitrile 20:80 V/V at flow rate 0.6 ml/min, ESI positive mode, and m/z 436à144.8, 338à296.2 for rivaroxaban and linezolid (as internal standard)respectively. As a clinical application, a bioequivalence study was conducted in a fully replicated crossover design involving 36 volunteers, where, AUC_0-t, AUC_0-inf, C_max, and T_max were calculated for the assessment of bioequivalence of test and reference products.

Results: The average recovery of Rivaroxaban was 98.675%. The limit of Quantitation was 0.5 ng/ml, and Correlation coefficient (r²) was equal to 0.9999. Statistical analysis of the measured parameters showed that there was no significant difference.

Conclusion: The developed LC/MS/MS bioanalytical method proved to be valid for the determination of rivaroxaban in human plasma and its pharmacokinetics application including comparative bioavailability studies which could be applied for therapeutic levels monitoring of rivaroxaban in management of blood coagulation associated with different diseases including COVID-19.

Keywords: Rivaroxaban; COVID-19; Venous Thromboembolism; LC/MS/MS; Factor Xa; Atrial Fibrillation

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Citation

Citation: Nagwa A Sabri., et al. “Rivaroxaban and Therapeutic Monitoring Application: Will it be a Significant Tool for Management of COVID-19?". Acta Scientific Pharmaceutical Sciences 4.11 (2020): 97-105.

Copyright

Copyright: © 2020 Nagwa A Sabri., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.