Abstract

Baliram Pandit Lawate*, Dinesh Sudarshan Gujrathi, Girishankar Haridas Bhavale, Shivshankar S. Wagdare and Ganesh P. Gosavi

ABSTRACT

Rivaroxaban, an anticoagulant, plays a vital role in inhibiting blood clot formation. In this study, a reverse phase high-performance liquid chromatography (RP-HPLC) method was developed for the determination of rivaroxaban in tablets (Rivaban-10 mg). The method is simple, specific, accurate, and precise for the quantification of rivaroxaban in both bulk drug and pharmaceutical dosage forms. The analysis was conducted using an Agilent C18 column (4.6 mm × 100 mm) maintained at room temperature. The mobile phase was a mixture of methanol and 0.1% formic acid in a 65:35 (v/v) ratio, delivered at a flow rate of 1.0 mL/min. The effluent was monitored at 253 nm using a photodiode array (PDA) detector, and the total analysis time was 15 minutes. The method was validated according to ICH guidelines, with parameters such as linearity, accuracy, precision, specificity, limit of detection (LOD), limit of quantification (LOQ), and robustness assessed. The linearity range for rivaroxaban was found to be 5–30 μg/mL, with a correlation coefficient of 0.9992. The recovery rate for rivaroxaban ranged from 98% to 102%. The LOD and LOQ were determined to be 0.1242 μg/mL and 0.3776 μg/mL, respectively. This RP-HPLC method is reliable and has been successfully applied to the quantitative determination of rivaroxaban in tablet dosage forms, making it suitable for use in quality control testing laboratories.