Miller J H, Pascal C, Tissieres M
J Chromatogr. 1987 Apr 17;392:361-70. doi: 10.1016/s0021-9673(01)94279-7.
A liquid chromatographic method is described for the determination of daunorubicin using octyldecylsilyl columns and sodium dodecyl sulphate as ion-pairing agent. The method based on previous publication [M. A. van Lancker et. al., J. Chromatogr., 254 (1983) 45] is specific for daunoribicin and separates it from likely impurities, e.g., the aglycone, duborimycin and related anthracyclines, doxorubicin and epirubicin. Several commercial batches have been examined in a number of laboratories employing various types of stationary phases. The intralaboratory reproducibilities varied from 1.0 to 1.6% and the interlaboratory reproducibility between 0.63 and 1.0% (based on the means of duplicate determinations), while with the preferred mobile phase the coefficient of variation was 0.3% (n = 4). The method is robust and is proposed for inclusion in a monograph on daunorubicin which is currently under consideration by the European Pharmacopoeia.
描述了一种使用十八烷基硅烷柱和十二烷基硫酸钠作为离子对试剂测定柔红霉素的液相色谱方法。该方法基于先前的文献[M. A. van Lancker等人，《色谱杂志》，254 (1983) 45]，对柔红霉素具有特异性，可将其与可能的杂质分离，例如糖苷配基、柔红霉素和相关蒽环类抗生素、阿霉素和表柔比星。多个实验室使用各种类型的固定相对多个商业批次进行了检测。实验室内的重现性在1.0%至1.6%之间，实验室间的重现性在0.63%至1.0%之间（基于重复测定的平均值），而使用优选的流动相时变异系数为0.3%（n = 4）。该方法稳健，建议纳入欧洲药典目前正在审议的柔红霉素专论中。
