Development of a validated RP-HPLC method for rivaroxaban quantification in pharmaceutical formulation and human blood plasma.

Abstract

Rivaroxaban is an anticoagulant used to prevent thromboembolism after hip or knee joint replacement surgery. The purpose of study was the development of an efficient, simple and economic reverse phase HPLC-PDA method for rivaroxaban determination in pharmaceutical dosage forms and blood plasma of human beings. The separation was carried out at room temperature by using Thermo Scientific ODS Hypersil C₁₈ (250×4.6mm, 5µm) and mobile phase 70:30 (%v/v) mixture of ACN / H₂O, 1.2 ml/min flow rate, detection on 253nm wavelength by PDA detector with run time of about 7 mins. The retention time observed was about 3 mins. The validation was performed on the proposed method in accordance with ICH guidelines and found that the method is linear within the range of 100-400µg/mL with the correlation coefficient 0.9996. The method was also precise, accurate, robust and rugged and showed specificity in all applied stress conditions i.e. photolytic (200-800nm, 3h) thermal (70°C, 2h), oxidative (3% H₂O₂ , 70^°C, 1h), acidic (0.1 N, 70^°C, 1h), and basic (0.1 N, 60^°C, 1h). This method was applied successfully for the Rivaroxaban quantitative determination in pharmaceutical dosage and human blood plasma.