An assay to determine rivaroxaban in pharmaceutical formulations by micellar liquid chromatography

Abstract

Rivaroxaban is one of the most prescribed anticoagulants. The ingestion of the correct dosage is a key to the success of the therapy. A procedure to evaluate the content of active principle ingredient in rivaroxaban pharmaceutical formulations, based on micellar liquid chromatography, has been developed. Tablets were solved in the mobile phase and directly injected, thus avoiding the use of large volumes of organic solvents. Analysis was performed using a C18 column and a mobile phase containing 0.05 M sodium dodecyl sulfate—12.5% 1-propanol, buffered at pH 7 with phosphate salt, running under isocratic mode at 1 mL/min. The analyte was resolved in less than 6.0 min. Detection was by UV absorption at 250 nm. The method was successfully validated by the guidelines of the International Conference of Harmonization in terms of specificity, calibration range (0.01–1.00 mg/L), linearity, limit of detection (0.002 mg/L), limit of quantification (0.006 mg/L), trueness (99.6–99.7%), precision (< 2%), robustness, system suitability, carry-over effect and stability, thus proven the adequate quality of the analytical results. A set of incurred and quality control samples was analyzed in the same run; and adequate results were obtained. The procedure was found practical, easy-to-conduct, rapid, safe, eco-friendly, inexpensive and with a high sample throughput; and then useful for routine analysis for pharmaceutical quality control purposes.