RP-HPLC Stability Indicating Method Development and Validation for Estimation of Rivaroxaban in Active Pharmaceuticals Ingredients

Abstract

Rivaroxaban is Anti-hypersensitive drug. In this study RP-HPLC stability indicating method was developed for Rivaroxaban in Active Pharmaceutical Ingredients. Hemochrom Intsil C18 (250mm X 4.6mm X 5µm) HPLC column was used at temperature 35°C.Gradient elution was achieved with 0.01M KH₂PO₄ Buffer and Acetonitrile-Water (20:80) v/v. The flow rate was 1.0 ml min^-1 wavelength used was 240 nm. Run time was kept 30 min. The development method was validated according to ICH guideline and found Linear over the range 50 µg ml^-1 to 500 µg ml^-1. The method was studied for force degradation i.e. stress studies parameter and method was capable for separation of degradation product and estimation of Rivaroxaban specifically, selectively, accurately and preciously.