RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form

Abstract

For the detection of Rivaroxaban in Pharmaceutical Tablet dosage form, a straightforward, rapid, highly selective, accurate, and exact reverse phase high performance liquid chromatographic (RP-HPLC) approach was designed and validated. The Adamas C8, (150 4.6mm, 5µm) column was used for the development, and the oven temperature used was 30°C. A 60:40% (v/v) combination of acetonitrile and water made up the solvent reservoir mobile phase. With a DAD detector, the flow rate was 1.0 ml per minute, and the wavelength was 253nm. The run time was limited to five minutes. Using EZ Chrome software, the separation was performed using an Agilent 1100 series HPLC. Rivaroxaban's retention period was measured at 3.680 minutes. According to ICH Q2 R1 recommendations, the method was validated in terms of parameters including linearity, accuracy, precision, specificity, limit of detection, limit of quantification, and robustness. With a correlation coefficient of 0.9998, the linearity was in the 10–50µg/ml range. Less than 2% was discovered to be the accuracy's relative standard deviation. The average recovery rate ranged from 100.12% to 101.58%. Limits of quantification and detection were discovered to be 0.3µg/ml and 1.0µg/ml, respectively. The suggested method for determining the dosage of Rivaroxaban in tablet form was successfully established.