QbD Based RP-HPLC Method Development and Validation of Rivaroxaban in Bulk and Pharmaceutical Formulation

Abstract

A simple, rapid, selective, and reproducible reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative estimation of Rivaroxaban in tablet dosage forms. The chromatographic separation was performed using a Waters XBridge C18 column (250 mm × 4.6 mm, 5 µm particle size). A mixture of acetonitrile and water in a ratio of 60:40 (v/v) was used as the mobile phase at a flow rate of 1.1 mL/min. Detection was carried out at a wavelength of 250 nm, and the column temperature was maintained at ambient conditions. The retention time of Rivaroxaban was found to be 5.458 minutes. The method demonstrated excellent linearity over the concentration range of 2–12 µg/mL, with a correlation coefficient of 0.9999, indicating a strong linear relationship between concentration and chromatographic response. Method precision was evaluated, and the percentage relative standard deviation (%RSD) values were found to be less than 2% at all selected concentrations, confirming the reproducibility of the developed method. Accuracy was assessed through recovery studies, which yielded a mean percentage recovery of 99.50%, demonstrating satisfactory agreement between the measured and expected drug concentrations. The assay results for Rivaroxaban in the commercially available tablet formulation were within the acceptable range of 98–102%. The method was validated in accordance with the applicable International Council for Harmonization (ICH) guidelines to establish its suitability for pharmaceutical analysis. The results indicate that the developed RP-HPLC method offers satisfactory linearity, precision, accuracy, and reproducibility under the specified chromatographic conditions. Therefore, the proposed method can be successfully applied to the routine quantitative analysis and quality control of Rivaroxaban in bulk drug and tablet dosage forms, subject to appropriate validation of specificity and other relevant performance characteristics.