Determination of the enantiomeric purity of a CNS agent, sumanirole, by electrokinetic chromatography

Journal of Liquid Chromatography and Related Technologies

Volumn 29, Issue 12, 2006, Pages 1703-1724

  Ramstad, Tore ^a   Mills, Kent ^a   Walker, Gustavus ^a  

^a PFIZER INC   (United States)

Author keywords

CD mediated electrokinetic chromatography; Chiral analysis; Chiral capillary electrophoresis; Enantiomeric excess of active pharmaceutical ingredient; Enantioseparation by capillary electrophoresis; Highly sulfated cyclodextrins

Indexed keywords

DISEASES; ELECTROLYTES; ELECTROPHORESIS; FUSED SILICA; ITERATIVE METHODS; SEPARATION;

CD-MEDIATED ELECTROKINETIC CHROMATOGRAPHY; CHIRAL ANALYSIS; CHIRAL CAPILLARY ELECTROPHORESIS; ENANTIOMERIC EXCESS OF ACTIVE PHARMACEUTICAL INGREDIENT; ENANTIOSEPARATION BY CAPILLARY ELECTROPHORESIS; HIGHLY-SULFATED CYCLODEXTRINS;

DRUG PRODUCTS;

BETA CYCLODEXTRIN; BUFFER; CENTRAL NERVOUS SYSTEM AGENTS; CYCLODEXTRIN; ELECTROLYTE; HIGHLY SULFATED BETA CYCLODEXTRIN; LITHIUM PHOSPHATE BUFFER; PHA 513550; PNU 105570; PNU 142774E; SILICON DIOXIDE; SUMANIROLE; UNCLASSIFIED DRUG;

ARTICLE; CAPILLARY ELECTROPHORESIS; CHIRALITY; CIRCULAR DICHROISM; CONCENTRATION (PARAMETERS); CORRELATION COEFFICIENT; DIASTEREOISOMER; DRUG FORMULATION; DRUG MANUFACTURE; ELECTRIC POTENTIAL; ENANTIOMER; LIMIT OF DETECTION; MICELLAR ELECTROKINETIC CHROMATOGRAPHY; PARKINSON DISEASE; PH; SEPARATION TECHNIQUE; VALIDATION PROCESS;

EID: 33745699281     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826070600716785     Document Type: Article

References (30)

1. Wang, F.; Khaledi, M.G. Enantiomeric separations by nonaqueous capillary electrophoresis. J. Chromatogr. A 2000, 875, 277-293.
2. Lämmerhofer, M. Chiral separations by capillary electromigration techniques in nonaqueous media: I. Enantioselective nonaqueous capillary electrophoresis. J. Chromatogr. A 2005, 1068, 3-30.
3. Scriba, G.K.E. Pharmaceutical and biomedical applications of chiral capillary electrophoresis and capillary electrochromatography: An update. Electrophoresis 2003, 24, 2409-2421.
4. Rizzi, A. Fundamental aspects of chiral separations by capillary electrophoresis. Electrophoresis 2001, 22, 3079-3106.
5. Amini, A. Recent developments in chiral capillary electrophoresis and applications of this technique to pharmaceutical and biomedical analysis. Electrophoresis 2001, 22, 3107-3130.
6. Vespalec, R.; Bocek, P. Chiral separations in capillary electrophoresis. Chem. Rev. 2000, 100, 3715-3753.
7. Chankvetadze, B. Enantiomer migration order in chiral capillary electrophoresis. Electrophoresis 2002, 23, 4022-4035.
8. Blaschke, G.; Chankvetadze, B. Enantiomer separation of drugs by capillary electromigration techniques. J. Chromatogr. A 2000, 875, 3-25.
9. Fanali, S. Enantioselective determination by capillary electrophoresis with cyclodextrins as chiral selectors. J. Chromatogr. A 2000, 875, 89-122.
10. Gübitz, G.; Schmid, M.G. Recent advances in chiral separation principles in capillary electrophoresis and capillary electrochromatography. Electrophoresis 2004, 23, 3981-3996.
11. Zhou, L.; Thompson, R.; Song, S.; Ellison, D.; Wyvratt, J.M. A strategic approach to the development of capillary electrophoresis chiral methods for pharmaceutical basic compounds using sulfated cyclodextrins. J. Pharm. Biomed. Anal. 2002, 27, 541-553.
12. Sänger-van de Griend, C.E.; Wahlström, H.; Gröningsson, K.; Widahl-Näsman, M. A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: validation and comparison with chiral liquid chromatography. J. Pharm. Biomed. Anal. 1997, 15, 1051-1061.
13. Zhou, L.; Johnson, B.D.; Miller, C.; Wyvratt, J.M. Chiral capillary electrophoretic analysis of the enantiomeric purity of a pharmaceutical compound using sulfated-β-cyclodextrin. J. Chromatogr. A 2000, 875, 389-401.
14. Sarac, S.; Chankvetadze, B.; Blaschke, G. Enantioseparation of 3,4-dihydroxyphenylalanine and 2-hydrazino-2-methyl-3-(3,4-dihydroxyphenyl) propanoic acid by capillary electrophoresis using cyclodextrins. J. Chromatogr. A 2000, 875, 379-387.
15. Mikus, P.; Valaskova, I.; Havranek, E. Enantioselective analysis of cetirizine in pharmaceuticals by cyclodextrin-mediated capillary electrophoresis. J. Sep. Sci. 2005, 28, 1278-1284.
16. de Pablos, R.R.; Garcia-Ruiz, C.; Crego, A.L.; Marina, M.L. Separation of etodolac enantiomers by capillary electrophoresis. Validation and application of the chiral method to the analysis of commercial formulations. Electrophoresis 2005, 26, 1106-1113.
17. Geiser, L.; Rudaz, S.; Veuthey, J.-L. Decreasing analysis time in capillary electrophoresis: validation and comparison of quantitative performances in several approaches. Electrophoresis 2005, 26, 2293-2302.
18. Bitar, Y.; Degel, B.; Schirmeister, T.; Holzgrabe, U. Development and validation of a separation method for the diastereomers and enantiomers of aziridine-type protease inhibitors. Electrophoresis 2005, 26, 2313-2319.
19. Rocheleau, M.-J. Generic capillary electrophoresis conditions for chiral assay in early pharmaceutical development. Electrophoresis 2005, 26, 2320-2329.
20. Vincent, J.B.; Vigh, G. Systematic approach to methods development for the capillary electrophoretic analysis of a minor enantiomer using a single-isomer sulfated cyclodextrin. J. Chromatogr. A 1998, 817, 105-111.
21. Nevado, J.J.B.; Cabanillas, C.G.; Llerena, M.J.V.; Robledo, V.R. Enantiomeric determination, validation and robustness studies of racemic citalopram in pharmaceutical formulations by capillary electrophoresis. J. Chromatogr. A 2005, 1072, 249-257.
22. Nishi, H. Enantiomer separation of drugs by electrokinetic chromatography. J. Chromatogr. A 1996, 735, 57-76.
23. Chankvetadze, B.; Blaschke, G. Enantioseparation in capillary electromigration techniques: recent developments and future trends. J. Chromatogr. A 2001, 906, 309-363.
24. Schmitt, U.; Branch, S.K.; Holzgrabe, U. Chiral separations by cyclodextrin-modified capillary electrophoresis-Determination of the enantiomeric excess. J. Sep. Sci. 2002, 25, 959-974.
25. Vescina, M.C.; Fermier, A.M.; Guo, Y. Comparing cyclodextrin derivatives as chiral selectors for enantiomeric separation in capillary electrophoresis. J. Chromatogr. A 2002, 973, 187-196.
26. de Boer, T.; de Zeeuw, R.A.; de Jong, G.J.; Ensing, K. Recent innovations in the use of charged cyclodextrins in capillary electrophoresis for chiral separations in pharmaceutical analysis. Electrophoresis 2000, 21, 3220-3239.
27. Evans, C.E.; Stalcup, A.M. Comprehensive strategy for chiral separations using sulfated cyclodextrins in capillary electrophoresis. Chirality 2003, 15, 709-723.
28. Sokoliess, T.; Köller, G. Approach to method development and validation in capillary electrophoresis for enantiomeric purity testing of active basic pharmaceutical ingredients. Electrophoresis 2005, 26, 2330-2341.
29. Vincent, J.B.; Kirby, D.M.; Nguyen, T.V.; Vigh, G. A family of single-isomer chiral resolving agents for capillary electrophoresis. 2. Hepta-6-sulfato-β-cyclodextrin. Anal. Chem. 1997, 69, 4419-4428.
30. Chen, F.-T.A.; Shen, G.; Evangelista, R.A. Characterization of highly sulfated cyclodextrins. J. Chromatogr. A 2001, 924, 523-532.