Development and validation of RP-HPLC method for the quantitative estimation of rivaroxaban in bulk and pharmaceutical dosage form

Rivaroxaban (RIV) is an oral anticoagulant, used in the treatment of thromboembolic ailments, myocardial infarction, stroke, angina pectoris and various blood clotting related disorders. A sensitive RP-HPLC method was developed for the quantitative estimation of RIV in bulk and pharmaceutical dosage form using Paracetamol as internal standard (IS). The separation of drug was achieved by C18 column using Acetonitrile and water as mobile phase at a ratio of 60:40%v/v with a flow rate and wavelength of 1ml/min and 254nm respectively. The retention time of RIV and IS were found to be 4.230 and 2.980 mins. The developed method was validated according to ICH (Q2) R1 guidelines over the concentration range of 100-500ng/ml. The LOD and LOQ were found to be 8.3325ng/ml and 25.25ng/ml. The method was found to be linear (R²=0.9992), specific, accurate, precised and robust.