Chemical profiling of pharmaceuticals by capillary electrophoresis in the determination of drug origin.
Capillary electrophoresis has been utilized to detect trace components in bulk pharmaceutical products, with emphasis on the identification of differences among manufacturers that can be used for source verification in suspect/counterfeit cases. Micellar electrokinetic capillary chromatography with sodium dodecyl sulfate was used in the analyses of beta-lactam antibiotics. The aminoglycoside clindamycin phosphate and the macrolide erythromycin stearate were analyzed using borate buffers with direct UV detection. Methyl-beta-cyclodextrin was used as a buffer additive in the erythromycin studies. Determination of product potency using peak area ratios has been demonstrated for ampicillin and clindamycin phosphate.
Flurer
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National Forensic Chemistry Center, US Food and Drug Administration, Cincinnati, OH 45202.
Wolnik
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D000900:Anti-Bacterial Agents / Q000032:analysis*; D002981:Clindamycin / Q000031:analogs & derivatives* / Q000032:analysis; D004586:Electrophoresis / Q000379:methods*; D004917:Erythromycin / Q000031:analogs & derivatives* / Q000032:analysis; D007769:Lactams; D015394:Molecular Structure; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D000900:Anti-Bacterial Agents; D007769:Lactams; D002981:Clindamycin; D004917:Erythromycin; C007084:clindamycin phosphate; C011462:erythromycin stearate