Analytical Method Development and Validation RP-HPLC Method for the Quantitative Determination of Rivaroxaban in Bulk and Pharmaceutical Formulation (Research Article)

Author(s): Payal Gunwant Borole, Charushila Bhangale and Atul N. Khadse

Abstract: In the present study, a new, sensitive, suitable, simple, precise, and robust reversed-phase high- performance liquid chromatography (RP-HPLC) method was developed and validated for the Rivaroxaban. Optimization was done by response surface methodology, applying Central Composite Design. Two factors selected were mobile phase composition, flow rate. The separation was carried on an HPLC system containing LC Solution software and HPLC Column C18 (250 x 4.6 mm),5µm. The detection was carried out at wavelength 250 nm. In the developed RP-HPLC method, 0.01M Sodium dihydrogen orthophosphate Buffer and Acetonitrile in the ratio of 40:60 v/v was used as mobile phase, at a flow rate of 1.0 mL/min and the retention time was found to be 4.4 min for Rivaroxaban. The results of the analysis in the method were validated in terms of linearity, accuracy, precision and specificity. The linearity of the developed method with a coefficient of correlation for the standard curve is 0.9991. The RSD for the precision of the method were found less than 2.0 %. The percentage recoveries of Rivaroxaban were found to be 100.19%. The developed and validated RP-HPLC method is robust, reproducible can be used for routine quality control in bulk and pharmaceutical dosage form in pharmaceutical industry.

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