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


Volume :

4

Issue :

4

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 HIBAR- 5μ 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.
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