Quantitative determination of rivaroxaban in pharmaceutical formulations by ultra performance liquid chromatography

Abstract

Rivaroxaban, which is a factor Xa inhibitor, effectively prevents clot formation in cardiovasculary system. In this study, a novel UPLC method was developed to provide an accurate, sensitive, fast, and reliable way for qualitative and quantitative analysis of rivaroxaban in pharmaceutical dosage forms. Chromatographic separation was achieved using a Phenomenex C18-bonded fused-core silica column (Kinetex® 2.6 μm, 150 mm × 3 mm i.d.). The separation was performed in isocratic mode with a mobile phase consisting of water, acetonitrile, and methanol (55:20:25, v/v/v), at a flow rate of 0.5 mL min-1, a column temperature of 40 °C, and a detection wavelength of 249 nm. The method was validated according to ICH Q2(R1) guideline for linearity, range, LOD and LOQ, accuracy, and precision and was successfully implemented to the analysis of rivaroxaban in tablet formulations.