ENANTIOMERIC SEPARATION OF RIVAROXABAN BY A CHIRAL LIQUID CHROMATOGRAPHIC METHOD
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 2
Abstract
Objective: To develop a novel,simple, selective and enantiomeric separation of rivaroxaban by a chiral liquid chromatographic method as per ICH guidelines.Methods: An enantioselective reversed phase high performance liquid chromatographic method was developed and validated. The enantiomers of rivaroxaban was resolved on a Chiralcel OD-H (250 mm × 4.6 mm, 5 mm) column using a mobile phase system containing n-hexane –isopropanol (50: 50 v/v/) and column temperature at 35°C. The resolution between the enantiomers was not less than 2.0. The developed method was validated according to ICH guidelines.Results: The calibration curve was found to be linear over the concentration range of 0.075–1.2µg/mL (r2= 0.9996). The limit of detection and limit of quantification of the (R)-enantiomer were found to be 0.025 and 0.075µg/mL, respectively, for 20 mL injection volume. The percentage recovery of the (R)-enantiomer ranged from 92.06 to 105.9 in bulk drug samples of rivaroxaban. The final optimized method was successfully applied to separate the (R)-enantiomer from rivaroxaban and was proved to be reproducible, accurate and robust for the quantitative determination of the (R)-enantiomer in Rivaroxaban.Conclusion: A novel, simple, selective and simple, selective and enantiomeric separation of rivaroxaban by a chiral liquid chromatographic method was developed as per ICH guidelines.Hence, the method can be used for routine analysis in pharmaceutical industry.Â
Authors and Affiliations
Swarup S. Prabhune, Vikram Dighe, Nitin S. Pradhan
Keywords
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