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Enantiomeric separation of Rivaroxaban
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인쇄
스크랩
Rivaroxaban은 OD-H로 키랄 분석이 가능합니다. 자한 내용은 첨부의 문헌을 통해 확인할 수 있습니다.
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.
Keywords: HPLC, Rivaroxaban, Chiral, Enantiomeric separation.
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