Flurer C L, Wolnik K A
National Forensic Chemistry Center, US Food and Drug Administration, Cincinnati, OH 45202.
J Chromatogr A. 1994 Jul 15;674(1-2):153-63. doi: 10.1016/0021-9673(94)85223-5.
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.
毛细管电泳已被用于检测原料药中的痕量成分，重点是识别不同制造商之间的差异，这些差异可用于可疑/假冒案件中的来源验证。采用十二烷基硫酸钠的胶束电动毛细管色谱法用于β-内酰胺类抗生素的分析。使用硼酸盐缓冲液并采用直接紫外检测法对氨基糖苷类克林霉素磷酸酯和大环内酯类硬脂酸红霉素进行了分析。在红霉素研究中，甲基-β-环糊精用作缓冲添加剂。已证明可使用峰面积比来测定氨苄西林和克林霉素磷酸酯的产品效价。
