Development of validated RP- HPLC method for estimation of rivaroxaban in pharmaceutical formulation

Abstract

A simple RP-HPLC method has been developed and validated for the estimation of Rivaroxaban in formulation.
Rivaroxaban is a direct factor Xa inhibitor which is indicated for the prevention various coagulative disorders. A HIBAR5μ C18 column (250×4.6mm) was used as a stationary phase. The mobile phase consisted of potassium dihydrogen
orthophosphate buffer (pH adjusted to 3.0 with orthophosphoric acid): Acetonitrile in the ratio of 60:40 % v/v and the flow
rate was 1 ml/min. The detection was carried in the room temperature at 248 nm. The retention time of Rivaroxaban was
7.45 min. The method was linear in the concentration range of 1-5 mcg/ml with correlation coefficient (r2
) of 0.9978. The
method was validated as per ICH guideline and it was successfully applied in the estimation of Rivaroxaban in the tablet
formulation.