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

•Dabigatran and rivaroxaban are target specific oral anticoagulants (TSOACs).•This is an analytical method to quantify simultaneously dabigatran and rivaroxaban in human plasma.•Dabigatran and rivaroxaban are stable in plasma 1 month at 3 different conditions of temperature.•It was successfully applied to 65 patient plasma samples. A sensitive and accurate liquid chromatography method with mass spectrometry detection was developed and validated for the quantification of dabigatran (Pradaxa®) and rivaroxaban (Xarelto®). 13C6-dabigatran and 13C6-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.