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Enantiomeric Impurity Determination in Capillary Electrophoresis Using a Highly-Sulfated Cyclodextrins-Based Method

Enantiomeric Impurity Determination in Capillary Electrophoresis Using a Highly-Sulfated Cyclodextrins-Based Method

Nele Matthijs, Yvan Vander Heyden

Biomed Chromatogr. 2006 Aug;20(8):696-709.

PMID: 16240285

Abstract:

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP1246816578	Chlorpheniramine Impurity A		1246816-57-8	Price

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