Capillary electrophoresis of drugs: current status in the analysis of pharmaceuticals.
The current status of capillary electrophoresis (CE) in pharmaceutical analyses is reviewed with about 300 references, mainly from 1996 until 1999. This article covers the use of CE for assay and purity determination of the main component, analysis of natural medicines, antisense DNA, peptides, and proteins. Analysis of hydrophobic and/or electrically neutral drugs by electrokinetic chromatography, capillary electrochromatography and nonaqueous CE is critically evaluated. Detailed techniques for the separation of enantiomers are given in the text with some actual applications. Furthermore, this review includes sensitivity and regulatory aspects for the actual use of CE in new drug applications (NDA). The analytical validation required for CE in NDA is also treated.
Nishi
H
H
Analytical Chemistry Department, Tanabe Seiyaku Co., Osaka, Japan. nishi-n@tanabe.co.jp
D016373:DNA, Antisense / Q000032:analysis / Q000737:chemistry; D017277:Drug Approval; D019075:Electrophoresis, Capillary / Q000379:methods* / Q000639:trends; D010455:Peptides / Q000032:analysis / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D011506:Proteins / Q000032:analysis / Q000737:chemistry; D013237:Stereoisomerism
D016373:DNA, Antisense; D010455:Peptides; D004364:Pharmaceutical Preparations; D011506:Proteins