不同色谱柱测定乙酰螺旋霉素原料及其制剂中各组分的含量

摘要

OBJECTIVE: To revise the system suitability requirements for acetylspiramycin and its preparation in Chinese Pharmacopeia (2005 edition). METHODS: Taking chromatogram of standard substance as standard, 4 kinds of column was used for the determination of 22 batches of acetylspiramycin and its preparations from 4 companies to inspect the content, resolution and column efficiency. RESULTS & CONCLUSIONS: Under previous condition, determination results are different according to the change of resolution. When chromatogram of samples are in line with retention time, impurity isolation and baseline of the current standard map of acetylspiramycin, the result is exact and accurate.%目的:对《中国药典》2005年版乙酰螺旋霉素原料及其制剂组分测定方法中“系统适用性”的控制要求进行修订.方法:以标准品图谱为标准,采用4款C18填料的色谱柱对4个厂家22个批次的原料及其制剂进行各组分的含量测定和分离度、柱效的考察.结果与结论:在原要求下,同一样品可因分离情况不同而导致测定结果的差异；只有在样品测定时记录的色谱与标准图谱中各组分的保留时间、分离杂质个数和杂质的基线分离完全一致的情况下,即以现行批乙酰螺旋霉素标准品的标准图谱作为“系统适用性”的控制,才可以保证测定结果的准确.