Spectrophotometric Analysis for the Quantification of Rivaroxaban in Bulk and Tablet Dosage Form

Objective This study reveals the report on the development of two spectrophotometric methods (A and B), for the determination of rivaroxaban in bulk and Xeralto tablets. Methods Method A involves the formation of colored tris (1, 10-phenanthroline)-iron (II) complex, upon reaction of rivaroxaban with iron (III)-1, 10-phenanthroline mixture in acidic media. The colored complex is spectrophotometrically measured at 525 nm. Method B involves the interaction of RXN with acetaldehyde with chloranil, to give colored vinylamino substituted quinones. The colored product exhibit absorption maxima at 655 nm. Effects of experimental variables on the determination of rivaroxaban have been examined and optimized. The proposed methods are validated by following ICH guidelines. Results Beer's law correlating the absorbance with rivaroxaban concentration was obeyed in the range of 5-62.5 μg/ml and 10-100 μg/ml, for methods A and B, respectively. Limits of detection and quantitation values were 0. 101μg/ml and 0.306μg/ml, respectively, for method A, and their respective values for method B were 0.116μg/ml and 0.351 μg/ml. The values of accuracy, precision, selectivity, robustness and ruggedness are within the adequate limit. The proposed method was applied successfully, for the quantification of rivaroxaban in Xeralto tablets, with good accuracy and precision. Conclusion The proposed methods A and B are valuable, in terms of its regular application in quality control assay of rivaroxaban