• Swarup S. Prabhune Wanbury Ltd.
  • Vikram Dighe Wanbury Ltd.
  • Nitin S. Pradhan Wanbury Ltd.


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.


Keywords: HPLC, Rivaroxaban, Chiral, Enantiomeric separation


Download data is not yet available.

Author Biography

Swarup S. Prabhune, Wanbury Ltd.
Analytical devlpoment department


1. Xarelto. Summary of Product Characteristics". Bayer Schering Pharma AG; 2008.

2. http://www.rxlist.com/xarelto-drug.htm
3. Roehrig S, Straub A, Pohlmann J, Lampe T, Pernerstorfer J. Discovery of thenovel antithrombotic agent 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide (BAY 59-7939) An oral, direct factorXa inhibitor. J Med Chem 2005;48:5900-8.
4. European Medicines agency. CHP Assessment Report for Xarelto; 2008.
5. Weinz C, Schwarz T, Kubitza D, Mueck W, Lang D. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Disposition 2009;37:1056-64.
6. Mustafa Celebier, Tuba Recber, Engin Kocak, Sacide Altınoz. RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms. BJPS 2013;49:2.
7. Lories IB, Mostafa AA, Girges MA. High performance liquid chromatography, TLC Densitometry, First-derivative and First-derivative ratio spectrophotometry fordetermination of rivaroxaban and its alkaline degradates in bulk powder and its tablets. J Chromatogr Sep Tech 2013;4-9.
8. Chandra Bala Sekaran, Vankayalapati Hima Bind, Mittapalli Rupa Damayanthi, Anaparthi Sireesha. Development and validation of UV spectrophotometric method for the determination of rivaroxaban. Der Pharm Chem 2013;5(4):1-5.
9. ICH Harmonized Tripartie Guidline Q2A Text on validation of analytical procedures; 2005.
713 Views | 1396 Downloads
How to Cite
Prabhune, S. S., V. Dighe, and N. S. Pradhan. “ENANTIOMERIC SEPARATION OF RIVAROXABAN BY A CHIRAL LIQUID CHROMATOGRAPHIC METHOD”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 7, no. 2, Dec. 2014, pp. 399-02, https://innovareacademics.in/journals/index.php/ijpps/article/view/4043.
Original Article(s)