A VALIDATED RP-HPLC METHOD FOR ESTIMATION OF RIVAROXABAN IN BULK AND TABLET 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 pharmaceutical dosage form. Chromatographic separation of Rivaroxaban was achieved on Prominence LC-20A Quaternary Gradient HPLC system, by using Shimpack C-18 (5μm, 4.6 x 250mm) column and the mobile phase containing Acetonitrile and Phosphate Buffer with pH of 4.5 in a 50:50 v/v ratio. The flow rate was 1.0ml/min; detection was carried out by absorption at 235nm using a UV detector at ambient temperature. LOD and LOQ were found to be 0.7497μg/ml and 2.272μg/ml respectively and retention time was found to be 4.848mins. The % Recovery was found to be 100.70-101.37%. The number of theoretical plates and tailing factor for Rivaroxaban were not less than 2000 and 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 method was found to be simple, economical, suitable, precise, accurate and robust method for quantitative analysis of Rivaroxaban.