The current status of capillary electrophoresis (CE) in pharmaceutical anal
yses is reviewed with about 300 references, mainly from 1996 until 1999. Th
is article covers the use of CE for assay and purity determination of the m
ain component, analysis of natural medicines, antisense DNA, peptides, and
proteins. Analysis of hydrophobic and/or electrically neutral drugs by elec
trokinetic chromatography, capillary electrochromatography and nonaqueous C
E is critically evaluated. Detailed techniques for the separation of enanti
omers are given in the text with some actual applications. Furthermore, thi
s review includes sensitivity and regulatory aspects for the actual use of
CE in new drug applications (NDA). The analytical validation required for C
E in NDA is also treated.