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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 0.1M 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.

Application of Stability Indicating HPLC Method with UV Detector to the Analysis of Rivaroxaban in Bulk and Tablet Dosage Form