White E R, Zarembo J E
J Antibiot (Tokyo). 1981 Jul;34(7):836-44. doi: 10.7164/antibiotics.34.836.
Improved methods for the separation and quantitation of cephalosporin, penicillin, aminoglycoside and anthracycline antibiotics are presented. The use of ultra high performance 5 micrometer phase columns combined with the added dimension of ion-pairing greatly increases the ease of separation and speed of analysis of complex antibiotic mixtures. Antibiotics in a variety of dosage forms and in fermentation broths have been examined in order to provide the maximum data on impurities to meet regulatory requirements for drug safety, purity and efficacy. Mixtures of antibiotics have been analyzed to demonstrate the improved separations, increased efficiency and shortened analysis times possible with ultra thin performance columns. Under these improved conditions, the danger of multiple components in a single peak are markedly reduced.
本文介绍了头孢菌素、青霉素、氨基糖苷类和蒽环类抗生素分离和定量的改进方法。使用超高效5微米相柱并结合离子对这一附加维度,大大提高了复杂抗生素混合物的分离简便性和分析速度。已对各种剂型和发酵液中的抗生素进行了检测,以便提供有关杂质的最大数据,以满足药品安全性、纯度和有效性的监管要求。已对抗生素混合物进行分析,以证明超薄性能柱可实现改进的分离、更高的效率和更短的分析时间。在这些改进条件下,单峰中出现多种成分的风险显著降低。