A New Method Development and Validation for Analysis of Rivaroxaban in Formulation by RP HPLC

A new simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid chromatography assay has been developed and validated for the estimation of Rivaroxaban in tablet formulation. The separation was achieved by using C-18 column (250x4.6mm, 5µm in particle size) at ambient temperature coupled with a guard column of silica in mobile phase Acetonitrile: Methanol: 0.1%Otho phosphoric acid (90:8:2) with the pH value adjusted to 4.06. The flow rate was 1.5ml/min and the drug was detected by using UV detector at the wavelength 234nm and the run time was 7min. The retention time was found 3.32 minutes. The percentage of RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per ICH guidelines. The proposed method was found to be accurate, repeatability and consistent. It can be successfully applied for the analysis of the drug in marketed formulation and could be effectively used for the routine analysis of the same drug without any alteration in the chromatographic conditions.