title: A strategic approach to the development of capillary electrophoresis chiral methods for pharmaceutical basic compounds using sulfated cyclodextrins.
abstract: Enantioseparations of basic pharmaceutical compounds were investigated using different types of sulfated cyclodextrins as chiral selectors. A general strategy for method development was described, together with enantiomeric separations of a number of pharmaceutical related compounds. Based on this strategy, systematic method development approaches for several selected compounds were performed by modifying method parameters, such as the concentration of the chiral selectors, buffer pH, type of organic modifiers, buffer type, temperature and applied voltage. The results of the investigation elucidated the separation mechanism. Many practical aspects were also discussed through several specific examples in order to demonstrate how to develop and validate a precise, sensitive, accurate and rugged separation.
authors.affiliation: Merck Research Laboratories, Merck and Co. Inc., P.O. Box 2000, Rahway, NJ 07065, USA. lili_zhou@merck.com
authors.forename: Lili
authors.initials: L
authors.lastname: Zhou
authors.forename: Richard
authors.initials: R
authors.lastname: Thompson
authors.forename: Sherry
authors.initials: S
authors.lastname: Song
authors.forename: Dean
authors.initials: D
authors.lastname: Ellison
authors.forename: Jean M
authors.initials: JM
authors.lastname: Wyvratt
mesh_terms: D003505:Cyclodextrins / Q000032:analysis* / Q000737:chemistry; D019075:Electrophoresis, Capillary / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000737:chemistry; D013237:Stereoisomerism; D013431:Sulfates / Q000032:analysis* / Q000737:chemistry
chemical_list: D003505:Cyclodextrins; D004364:Pharmaceutical Preparations; D013431:Sulfates