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

Abstract

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, 5 µm), 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 (r 2 = 0.99995).The Drug was subjected to base degradation. The method was found to be robust and suitable for routine analysis of Rivaroxaban. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the method is thus stability-indicating.