Electrochemical behaviour investigation and square-wave voltammetric determination of rivaroxaban in pharmaceutical dosage forms

Abstract

Rivaroxaban, an oral oxazolidinone-based anticoagulant, is a potent, selective direct inhibitor of factor Xa, which is used in the prevention of venous thromboembolism in adult patients after total hip replacement or total knee-replacement surgery. Because there are no reports about the electrochemical behaviour of rivaroxaban and its analytical application, its electrochemical behaviour was investigated at a hanging mercury-drop electrode using square-wave and cyclic voltammetry. For this purpose, the square-wave voltammetric method in electrolytes of different pH and buffers was used. Rivaroxaban showed a reduction peak between pH ranges from 7 to 11. The optimum conditions were obtained using Britton–Robinson buffer at pH 8.0 and a frequency of 80 Hz, a scan increment of 5 mV and pulse amplitude of 25 mV. A well-defined peak current was observed at a hanging mercury-drop electrode of −1770 mV vs. Ag/AgCl reference electrode. The cyclic voltammogram of rivaroxaban exhibited a single peak at the same peak potential as the obtained square-wave voltammogram, and the reduction reaction was irreversible. This response was determined to be related to the electroactive part of the molecule of rivaroxaban. The developed method was validated according to the ICH guideline. Validation parameters, such as linearity, sensitivity, specificity, precision and accuracy, for the developed method were evaluated. The developed method was successfully used for the determination of rivaroxaban in tablets. The results obtained from tablets were compared with the high-performance liquid chromatographic method in the literature to assess active rivaroxaban content, and no statistically significant difference was determined.