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Chromatographia

, Volume 66, Issue 5–6, pp 389–393 | Cite as

Chiral Separation of Duloxetine and Its R-Enantiomer by LC

  • Jing Yang
  • Xiumei Lu
  • Yujin Bi
  • Feng Qin
  • Famei LiEmail author
Full Short Communication

Abstract

The direct enantioseparation of duloxetine and its R-enantiomer was achieved by HPLC using hydroxypropyl-β-cyclodextrin (HP-β-CD) as a chiral selector and a vancomycin chiral stationary phase (Chirobiotic V). Operational parameters, such as the concentration of HP-β-CD, buffer pH, organic modifiers, temperature and flow rate, were varied in order to achieve the desired retention time and resolution. These two enantioseparation methods developed gave a baseline resolution of the enantiomers. Finally, the HPLC-CSP method was selected to determine the enantiomeric purity of duloxetine drug substance due to its much shorter analysis time and better resolution. The limit of detection of this method was 0.06 μg mL−1.

Keywords

Column liquid chromatography Chiral stationary phase Chiral mobile phase additive Duloxetine 

Notes

Acknowledgments

The authors gratefully thank Prof. J. Dong from the School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, China, for the generous gift of duloxetine and its R-enantiomer.

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Copyright information

© Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH 2007

Authors and Affiliations

  • Jing Yang
    • 1
  • Xiumei Lu
    • 1
  • Yujin Bi
    • 1
  • Feng Qin
    • 1
  • Famei Li
    • 1
    Email author
  1. 1.Department of Analytical ChemistryShenyang Pharmaceutical UniversityShenyangChina

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