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.
Cite this article:
Kasad Pinaz A., K.S. Muralikrishna. Method Development and Acid Degradation Study of Rivaroxaban by RP-HPLC in bulk. Asian J. Pharm. Ana. 3(2): April- June 2013; Page 62-65.