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Enantiomeric impurity determination in capillary electrophoresis using a highly‐sulfated cyclodextrins‐based method
Author(s) -
Matthijs Nele,
Heyden Yvan Vander
Publication year - 2006
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.585
Subject(s) - capillary electrophoresis , chemistry , enantiomer , chromatography , impurity , resolution (logic) , cyclodextrin , organic chemistry , artificial intelligence , computer science
Capillary electrophoresis (CE), using highly‐sulfated cyclodextrins as chiral selectors, has been applied to determine the chiral purity of pharmaceutical compounds. A chiral separation strategy, developed earlier for racaemic mixtures, was applied on four basic drugs (propranolol, atenolol, chlorpheniramine and tryptophan methylester). The aim was to develop validated separation methods which allow determination of 0.1% impurity levels of the unwanted enantiomers (distomer) in the presence of 99.9% of the active compound (eutomer). The linearity, quantification limits for the trace enantiomers and the precision of the measurements were determined. In a second part, impurity separations have been simulated in order to evaluate the required resolution when assaying impurities. It is shown that a baseline resolution of 1.5, generally accepted for racaemic mixtures, does not always allow good impurity determinations. Two alternative methods to solve this problem have been proposed. Copyright © 2005 John Wiley & Sons, Ltd.