Rivaroxaban – Analytical Method Development and Validation

Abstract

A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitation of Rivaroxaban in bulk drug and pharmaceutical dosage form. The quantification is carried out with a HiQSil C18 (250 mm x 4.6 mm, 5 µm) column maintained at room temperature with mobile phase consisted of a mixture of methanol and water in the ratio of 65:35 v/v delivered at a flow rate of 1.4 ml/min and effluents were monitored at 249 nm through JASCO UV-4075 UV-VIS detector. The retention time of Rivaroxaban was found to be 3.12 min. The method was validated as per ICH guidelines, parameters like linearity, accuracy, precision, specificity, limit of detection, limit of quantitation and robustness. The linearity was in the range of 5 – 30 µg/ml with correlation coefficient of 0.9995. The recovery of Rivaroxaban was found to be 100%. Limit of detection and limit of quantitation were found to be 1.12 µg/ml and 2.02 µg/ml respectively. The proposed method was successfully applied for the quantitative determination of Rivaroxaban in tablet dosage form in quality control testing laboratories.