Method Development and Acid Degradation Study of Rivaroxaban by RP-HPLC in bulk

A simple, precise and accurate HPLC method has been developed and validated for assay of Rivaroxaban. An isocratic separation was achieved using a phenomenex C18(250×4.6 mm, 5μm),100°A particle size columns with a flow rate of 1 ml/min and using a PDA detector to monitor the elute at 250 nm. The mobile phase consisted of Methanol: Acetronitrile (50:50, v/v). The method was validated for specificity, linearity, precision, accuracy and robustness. The method was linear over the concentration range of 20–100 μg/ml (r²= 0.99995). Intraday system and method precision were determined and accuracy was 99.89%. The method was found to be robust and suitable for assay of Rivaroxaban in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the assay is thus stability-indicating.