Determination of rivaroxaban in patient's plasma samples by anti-Xa chromogenic test associated to High Performance Liquid Chromatography tandem Mass Spectrometry (HPLC-MS/MS).
Rivaroxaban is an oral direct factor Xa inhibitor, therapeutically indicated in the treatment of thromboembolic diseases. As other new oral anticoagulants, routine monitoring of rivaroxaban is not necessary, but important in some clinical circumstances. In our study a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was validated to measure rivaroxaban plasmatic concentration. Our method used a simple sample preparation, protein precipitation, and a fast chromatographic run. It was developed a precise and accurate method, with a linear range from 2 to 500 ng/mL, and a lower limit of quantification of 4 pg on column. The new method was compared to a reference method (anti-factor Xa activity) and both presented a good correlation (r = 0.98, p < 0.001). In addition, we validated hemolytic, icteric or lipemic plasma samples for rivaroxaban measurement by HPLC-MS/MS without interferences. The chromogenic and HPLC-MS/MS methods were highly correlated and should be used as clinical tools for drug monitoring. The method was applied successfully in a group of 49 real-life patients, which allowed an accurate determination of rivaroxaban in peak and trough levels.
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Priscilla Bento Matos
PB
Derogis
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Livia Rentas
LR
Sanches
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Valdir Fernandes
VF
de Aranda
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Marjorie Paris
MP
Colombini
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Cristóvão Luis Pitangueira
CL
Mangueira
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Marcelo
M
Katz
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Adriana Caschera Leme
AC
Faulhaber
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Claudio Ernesto Albers
CE
Mendes
Hospital Israelita Albert Einstein, São Paulo, Brazil.
Carlos Eduardo Dos Santos
CE
Ferreira
Santo Amaro University-UNISA, São Paulo, Brazil.
Carolina Nunes
CN
França
Hospital Israelita Albert Einstein, São Paulo, Brazil.
João Carlos de Campos
JC
Guerra
D001780:Blood Coagulation Tests; D002851:Chromatography, High Pressure Liquid; D016903:Drug Monitoring; D065427:Factor Xa Inhibitors / Q000493:pharmacokinetics* / Q000627:therapeutic use; D006801:Humans; D015203:Reproducibility of Results; D000069552:Rivaroxaban / Q000493:pharmacokinetics* / Q000627:therapeutic use; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry
D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban