Abstract

A simple and sensitive stability indicating HPLC method is developed for the quantification of rivaroxaban in bulk and tablet dosage form. Chromatographic separation was achieved on an ACE-Ciano column (250 mm x 4.6 mm, 5 μm particle size). The mobile phase consists of 0.1 M sodium acetate and methanol (60:40 v/v) and was delivered at a flow rate of 1 mL/min. A UV detector was used for the detection. The rivaroxaban was subjected to stress conditions for the assessment of the stability-indicating nature of the method. The method was validated as per ICH guidelines. The linearity is obtained in the range of 1-120 μg/mL. The limit of detection and quantification values is 0.194 μg/mL and 0.648 μg/mL respectively. The intra and inter-day %RSD values were below 1%. Intra and inter-day accuracies were within 100.10% and 100.40%, respectively. Degradation products resulting from the stress studies have no interfere with the detection of rivaroxaban. The average recovery of rivaroxaban in tablet dosage form was 99.74% with %RSD of 0.421%. The developed method was proved adequate for quantitative determination of rivaroxiban in presence of its degradation products.

Keywords

Analysis, HPLC, Rivaroxaban, Stability indicating, Tablets