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Generic capillary electrophoresis conditions for chiral assay in early pharmaceutical development
Author(s) -
Rocheleau MarieJosée
Publication year - 2005
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/elps.200410265
Subject(s) - capillary electrophoresis , chromatography , cyclodextrin , enantioselective synthesis , chemistry , sulfation , beta cyclodextrins , enantiomer , combinatorial chemistry , stereochemistry , organic chemistry , biochemistry , catalysis
Generic capillary electrophoresis (CE) conditions have been implemented for chiral separations in early pharmaceutical development. The chiral CE separations of several pharmaceutical samples at different stages of development, i.e. , discovery, process chemistry, and investigative new drug application, have been obtained using sulfated β‐cyclodextrin (CD). Several sulfated β‐CDs have been screened to select an appropriate enantioselective agent. The use of a generic CE method allows for a convenient and rapid chiral recognition of different weak bases, with minimal or no method development. CE using sulfated β‐CD for the chiral separation of N ‐benzoyl methyl piperazine has been validated for linearity, precision, accuracy, limits of detection and quantitation (LOD, LOQ). Although less sensitive than a specific liquid chromatography method using a Chiralpak® AD column, the overall performance of the chiral CE method was found comparable. Validation data demonstrate that a LOD of 0.1%, sufficient to fulfill regulatory requirements, is achievable by chiral CE.