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A strategic approach to the development of capillary electrophoresis chiral methods for pharmaceutical basic
Lili Zhou1, Richard Thompson, Sherry Song
1Merck Research Laboratories, Merck and Co. Inc., P.O. Box 2000, Rahway, NJ 07065, USA. lili_zhou@merck.com
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.
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