Role of capillary electrophoresis methods in the drug development process

Chirality

Volumn 8, Issue 1, 1996, Pages 108-121

  Rickard, Eugene C ^a   Bopp, Ronald J ^b   Skanchy, David J ^c   Chetwyn, Kerri L ^c   Fahlen, Bettina ^c   Stobaugh, John F ^c  

^a ELI LILLY AND COMPANY   (United States)

^b Chiral Technologies Inc   (United States)

^c UNIVERSITY OF KANSAS   (United States)

Author keywords

achiral; chiral purity; cyclodextrin; pharmaceutical; purity; SBE cyclodextrin

Indexed keywords

CYCLODEXTRIN; DULOXETINE;

CAPILLARY ELECTROPHORESIS; CHIRALITY; CONFERENCE PAPER; DRUG DETERMINATION; DRUG INDUSTRY; DRUG PURITY; ENANTIOMER; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL;

EID: 0029865409     PISSN: 08990042     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1520-636X(1996)8:1<108::AID-CHIR16>3.0.CO;2-R     Document Type: Conference Paper

References (26)

1. FDA. Food and Drug Administration's policy statement for the development of new stereoisomeric drugs. Chirality 4:338-340, 1992.
2. Report to the International Conference on Harmonization Steering Committee. International harmonization of regulatory requirements for chiral drugs. Tokyo, September 15, 1992.
3. Rauws, A. G., Groen, K. Current regulatory (draft) guidance on chiral medicinal products: Canada, EEC. Japan, United States. Chirality 6:72-75, 1994.
4. Holmes, K. D. Comments on enantiomerism in the drug development process. Pharmaceut. Tech. 14:46-52, 1990.
5. Stinson, S. C. Chiral drugs. Chem. Eng. News 70:41-79, September 28, 1992.
6. Tomaszewski, J., Rumore, M.M. Stereoisomeric drugs: FDA's policy statement and the impact on drug development. Drug Dev. Indust. Pharm. 20:119-139, 1994.
7. Wozniak, T.J., Bopp, R.J., Jensen, E.C. Chiral drugs: An industrial analytical perspective. J. Pharmaceut. Biomed. Anal. 9:363-382, 1991.
8. Wozniak, T.J. Quality Control for Chiral Drug Products. Reston, VA: Chiral USA 93, May 1993.
9. Armstrong, D.W., Li, W., Chang, C-D., Pitha, J. Polar-liquid, derivatized cyclodextrin stationary phases for the capillary gas chromatography separation of enantiomers. Anal. Chem. 62:914-923, 1990.
10. Siret, L., Tambute, A., Rocca, P., Caude, M. Separation des stereoisomeres de l'acide norbornyl-2-(thienyl-3)-2-glycolique. Analusis 20:375-378, 1992.
11. Altria, K.D., Dave, Y K. Peak homogeneity determination and micropreparative fraction collection by capillary electrophoresis for pharmaceutical analysis. J. Chromatogr. 633:221-225, 1993.
12. Bopp, R.J., Wozniak, T.J., Zynger, J., Rickard, E.C. Chiral Separations: Options for Problem-Solving in Industry. Edinburgh, Scotland: Pharm-Analysis Europe, October 1993.
13. Schmitt, T., Engelhardt, H. Charged and uncharged cyclodextrins as chiral selectors in capillary electrophoresis. Chromatographia 37:475-481, 1993.
14. Schmitt, T., Engelhardt, H. Denvatized cyclodextrins for the separation of enantiomers in capillary electrophoresis. J. High Resol. Chromatogr. 16:525-529, 1993.
15. Smith, N.W. Separation of positional isomers and enantiomers using capillary zone electrophoresis with neutral and charged cyclodextrins. J. Chromatogr. A 652:259-262, 1993.
16. Nardi, A., Eliseev, A., Bocek, P., Fanali, S. Use of charged and neutral cyclodextrins in capillary zone electrophoresis: Enantiomeric resolution of some 2-hydroxy acids. J. Chromatogr. 638:247-253, 1993.
17. Tait, R.J., Thompson, D.O., Stella, V.J., Stobaugh, J.F. Sulfobutyl ether β-cyclodextrin as a chiral discriminator for use with capillary electrophoresis. Anal. Chem. 66:4013-4018, 1994.
18. Lurie, I.S., Klein, R.F.X., Dal Cason, T.A., LeBelle, M.J., Brenneisen, R., Weinberger, R.E. Chiral resolution of cationic drugs of forensic interest by capillary electrophoresis with mixtures of neutral and anionic cyclodextrins. Anal. Chem. 66:4019-4026, 1994.
19. Chankvetadze, B., Endresz, G., Blaschke, G. About some aspects of the use of charged cyclodextrins for capillary electrophoresis enantioseparation. Electrophoresis 15:804-807, 1994.
20. Tait, R.J., Skanchy, D.J., Thompson, D.P., Chetwyn, N.C., Dunshee, D.A., Rajewski, R.A., Stella, V.J., Stobaugh, J.F. Characterization of sulphoalkyl ether derivatives of β-cyclodextrin by capillary electrophoresis with indirect UV detection. J. Pharmaceut. Biomed. Anal. 10:615-622, 1992.
21. Rajewski, R.A. Development and Evaluation of the Usefulness and Parenteral Safety of Modified Cyclodextrins. Ph. D. Thesis. Lawrence, KS: University of Kansas, January 1990.
22. Bopp, R.J., Rickard, E.G. Comparative Utility: Use of CE vs. HPLC for Determination of Chiral Drug Purity. Orlando, FL: HPCE'93, January 1993.
23. Rickard, E.C., Bopp, R.J. Optimization of a capillary electrophoresis method to determine the chiral purity of a drug. J. Chromatogr. A, 680: 609-621, 1994.
24. Penn, S.G., Goodall, D.M., Loran, J.S. Differential binding of tioconazole enantiomers to hydroxypropyl-β-cyclodextrin studied by capillary electrophoresis. J. Chromatogr. 636:149-152, 1993.
25. Wren, S.A.C., Rowe, R.C. Theoretical aspects of chiral separation in capillary electrophoresis: I. Initial evaluation of a model. J. Chromatogr. 603:235-241, 1992.
26. Snopek, J., Soini, H., Novotny, M., Smolkova-Keulemansova, E., Jelinek, I. Selected applications of cydodextrin selectors in capillary electrophoresis. J. Chromatogr. 559:215-222, 1991.