DEVELOPMENT AND VALIDATION OF RIVAROXABAN BY USING RP- HPLC METHOD IN BULK AND PHARMACEUTICAL DOSAGE FORM

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Rivaroxaban in bulk & pharmaceutical dosage form.Chromatographic separation of Rivaroxaban was achieved on Waters Alliance-e2695, by using Agilent SB C18 (250mm x 4.6mm, 3.5m) column and the mobile phase containing ACN and 0.1% Formic acid in the ratio of 70:30% v/v.The flow rate was 0.8 ml/min; detection was carried out by absorption at 269nm using a photodiode array detector at ambient temperature.The number of theoretical plates and tailing factor for Rivaroxaban were NLT 2000 and should not more than 2 respectively.% Relative standard deviation of peak areas of all measurements always less than 2.0.The proposed method was validated according to ICH guidelines.The RP-HPLC method was found to be linear over the concentration range from 12.5-75 g/ml with correlation coefficient of (r 2 ) 0.99978.theretention time for bulk rivarobaxan was found to be 3.029 min.LOQ of method was 0.5 g/ml and LOD of method was found to be 0.15 g/ml.The method was found to be simple, economical, suitable, precise, accurate & robust method which can be applied for the regular analysis of rivarobaxan in bulk as well as pharmaceutical dosage form.