ROLE OF CAPILLARY ELECTROPHORESIS METHODS IN THE DRUG DEVELOPMENT PROCESS

In the past several years, capillary electrophoresis (CE) has generate d considerable interest from pharmaceutical companies for control of b oth the chiral and achiral purity of bulk drugs and drug products. Thi s paper evaluates the use of CE as: (1) a technique complementary to H PLC for the determination of peak homogeneity of a drug, (2) for deter mination of chiral purity, and (3) for determination of achiral purity . It would be greatly advantageous if CE could be used to determine bo th the chiral and achiral purity in a single assay. This investigation compares the results obtained for the separation of the enantiomers o f duloxetine using several neutral cyclodextrins to those obtained usi ng anionic cyclodextrins (sulfobutyl ether derivatives) as chiral sele ctors added to the separation buffer. In addition, it reports chiral s eparations obtained by using neutral cyclodextrins in a sulfonic acid- coated capillary column, which give a negatively charged capillary sur face and electroosmotic now even in low pH buffers. The possible mecha nism of separation is discussed. (C) 1996 Wiley-Liss, Inc.