Chiral Purity Test of Bevantolol by Capillaryelectrophoresis and High Performance Liquid Chromatography

  • 발행 : 2006.09.01

초록

Two methods for the chiral purity determination of bevantolol were developed, namely capillary electrophoresis (CE) using carboxymethyl-${\beta}$-cyclodextrin (CM-${\beta}$-CD) as a chiral selector and high-perfomance liquid chromatography (HPLC) using a chiral stationary phase. In the HPLC method, the separation of bevantolol enantiomers was performed on a Chiralpak AD-H column by isocratic elution with n-hexane-ethanol-diethylamine (10:90:0.1, v/v/v) as mobile phase. In the CE method, bevantolol enantiomers were separated on an uncoated fused silica capillary with 50 mM amonium phosphate dibasic adjusted to a pH 6.5 with phosphoric acid containing 15 mM CM-${\beta}$-CD as running buffer. Validation data such as linearity, recovery, detection limit, and precision of the two methods are presented. The detection limits of S-(-)-bevantolol were 0.1% and 0.05% for CE and HPLC method, respectively and R-(+)-bevantolol were 0.15% and 0.05% for CE and HPLC method, respectively. There was generally good agreement between the HPLC and CE results.

키워드

참고문헌

  1. Aboul-Enein, H. Y. and Serignese, V., Direct enantioselective separation of bevantolol by high-performance liquid chromatography on normal and reverse cellulose chiral stationary phases. Biomed. Chromatogr., 8(1), 22-25 (1994) https://doi.org/10.1002/bmc.1130080106
  2. Barret, A. M. and Uhum, V. A., The biological properties of the optical isomer of propranolol and their effect on cardiac arthythmias. Br.J. pharmacol., 13, 43 (1968)
  3. Drayer, D. E., Pharmacodynamic and pharmacokinetic differences between drug enantiomers in humans: an overview. Clin. Pharmacol. Ther., 2, 125-133 (1986)
  4. Drayer, D. E., Problems in therapeutic drug monitoring: the dilemma of enantiomeric drugs in man. Ther Drug Monit., 1, 1-7 (1988) https://doi.org/10.1097/00007691-197901000-00001
  5. Fanali, S., Cartacini, P.,Blaschke, G., and Chankvetadze, B., Enantioseparations by capilllary electrochromatography. Electrophoresis, 22, 3131-3151 (2001) https://doi.org/10.1002/1522-2683(200109)22:15<3131::AID-ELPS3131>3.0.CO;2-S
  6. Fillet, M., Bechet, I., Chiap, P., Hubert, Ph., and Crommen, J., Enantiomeric purity determination ofproprannolol by cyclodextrin- modified capillary electrophresis. J. Chromatogr A., 717, 203-209 (1995) https://doi.org/10.1016/0021-9673(95)00503-6
  7. Maier, V., Horakova, J., Petr, J., Tesarova, E., Coufal, P., and Sevcik, J., Chiral separation of Tamsulosin by capillary electrophoresis. J. Pharm. Biomed. Anal., 39, 691- 696 (2005) https://doi.org/10.1016/j.jpba.2005.04.023
  8. Min, H., Shulin, Z., and Jie, C., Chiral separation of Penicillamine Enantiomers by capillary electrophoresis and its application. Chin J Anal Chem., 34(5), 655-658 (2006) https://doi.org/10.1016/S1872-2040(06)60035-2
  9. Nishi, H., Enantiomer separation of drugs by electrokinetic chromatography. J.Chromatogr. A., 735, 57-76 (1996) https://doi.org/10.1016/0021-9673(95)01262-1
  10. Rose, S. E. and Randinitis, E. J., A high-performance liquid chromatographic assay for the enantiomers of bevantolol in human plasma. Pharm. Res., 8(6), 758-762 (1991) https://doi.org/10.1023/A:1015858219018
  11. Sänger-van de Griend, C. E., Anders, G. E., Monica, E., Widahl- Näsman, E. K., and Andersson, M., Method development for the enantiomeric purity determination of low concentration of adrenaline in local anaesthetic solutions by capillary electrophoresis. J. Pharm. Biomed. Anal., 41, 77-83 (2006) https://doi.org/10.1016/j.jpba.2005.10.012
  12. Veleysen, K. and Sandra, P., Separation of chiral compounds by capillary electrophoresis. Electrophoresis, 19, 2798-2833 (1998) https://doi.org/10.1002/elps.1150191607
  13. Wei, S., Guo, H., and Lin, J., Chiral separation of salbutamol and bupivacaine by capillary electrophoresis using dual neutral cyclodextrin as selectors and its application to pharmaceutical preparations and rat blood samples assay. J.Chromatogr. B., 832, 90-96(2006) https://doi.org/10.1016/j.jchromb.2005.12.044
  14. Williams, K. and Lee, E., Importance of drug enantiomers in clinical pharmacology. Drugs, 4, 333-54 (1985)