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

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Concept, Design & Programming
Dr. Adrian Man

Nr. 25(2)/2017 DOI:10.1515/rrlm-2017-0007

Research article

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

Andreea Varga, Răzvan Constantin Șerban, Daniela Lucia Muntean, Cristina Maria Tătar, Lenard Farczadi, Ioan Tilea

Correspondence should be addressed to: Răzvan Constantin Șerban

Abstract:

A rapid, sensitive, high-throughput liquid chromatography coupled with tandem mass spectrometry method for the quantification of rivaroxaban from human plasma has been developed and validated. For the analytical separation a Zorbax SB-C18 column with isocratic flow of mobile phase composed of 0.2% formic acid in water and acetonitril (65:35, V/V) with a flow rate of 1 mL/min at a temperature of 45ºC was used. Detection of rivaroxaban was performed using positive electrospray ionization and MS/MS mode (sum of m/z 231.1; 289.2 and 318.2 from m/z 436.3). Plasma samples were prepared using single-step protein precipitation with methanol. Method validation was performed with regards to selectivity, linearity (r >0.9927), within-run and between-run precision (CV< 13.1 %) and accuracy (bias< 9.4 %) over a concentration range of 24.00 - 960.00 ng/mL plasma. Recovery was between 96.5 - 108.5% and the lower limit of quantification of rivaroxaban was 24.00 ng/mL. The developed method is simple, rapid, and selective, requires small plasma sample volumes, and was successfully applied for therapeutic drug monitoring of rivaroxaban in treated patients.

Keywords: Anticoagulants, direct factor Xa inhibitors, rivaroxaban, LC-MS/MS, therapeutic drug monitoring

Received: 6.11.2016
Accepted: 17.1.2017
Published: 7.3.2017

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Varga A, Șerban RC, Muntean DL, Tătar CM, Farczadi L, Tilea I. Rapid liquid chromatography tandem mass spectrometry determination of rivaroxaban levels in human plasma for therapeutic drug monitoring. Rev Romana Med Lab. 2017;25(2):145-55. DOI:10.1515/rrlm-2017-0007