Simultaneous determination of rivaroxaban and dabigatran levels in human plasma by high-performance liquid chromatography-tandem mass spectrometry

J Pharm Biomed Anal. 2014 Nov;100:230-235. doi: 10.1016/j.jpba.2014.08.011. Epub 2014 Aug 15.

Abstract

A sensitive and accurate liquid chromatography method with mass spectrometry detection was developed and validated for the quantification of dabigatran (Pradaxa(®)) and rivaroxaban (Xarelto(®)). (13)C6-dabigatran and (13)C6-rivaroxaban were used as the internal standard. A single-step protein precipitation was used for plasma sample preparation. This method was validated with respect to linearity, selectivity, inter- and intra-day precision and accuracy, limit of quantification and stability. The lower limit of quantification was 2.5ng/mL for both drugs in plasma.

Keywords: Dabigatran; LC–MS/MS; Mass spectrometry; Rivaroxaban; TSOAC.

Publication types

  • Validation Study

MeSH terms

  • Antithrombins / blood*
  • Benzimidazoles / blood*
  • Calibration
  • Chromatography, High Pressure Liquid* / standards
  • Cold Temperature
  • Dabigatran
  • Drug Monitoring / methods*
  • Drug Monitoring / standards
  • Drug Stability
  • Factor Xa Inhibitors / blood*
  • Humans
  • Limit of Detection
  • Linear Models
  • Molecular Structure
  • Morpholines / blood*
  • Reference Standards
  • Reproducibility of Results
  • Rivaroxaban
  • Tandem Mass Spectrometry* / standards
  • Thiophenes / blood*
  • Time Factors
  • beta-Alanine / analogs & derivatives*
  • beta-Alanine / blood

Substances

  • Antithrombins
  • Benzimidazoles
  • Factor Xa Inhibitors
  • Morpholines
  • Thiophenes
  • beta-Alanine
  • Rivaroxaban
  • Dabigatran