摘要
系统考察了HPLC分析庆大霉素发酵液C组份中各种因素的影响．如不同型号的ODS柱，不同的流动相配比，用甲酸代替冰醋酸以及不同的发酵液前处理方法等。在上述研究基础上建立的在Waters－Nova－PakC184μm3．9×150mm柱上，以庚烷磺酸钠浓度（5．0g／L）甲醇：水：甲酸＝74：21：5为流动相系统，在20min内即可完成样品分析，且C1峰与相邻杂质峰获得了良好分离。本法首次采用甲酸取代药典规定的流动相中的冰醋酸，使庆大霉素发酵液组份C1峰与相邻杂质峰的分离效果显著，为今后庆大霉素发酵液的质量控制及其质量标准的改进，提供了新的有效途径。
Systematic study on HPLC analysis is carried out for factors,such as different type of ODS cohumn,proportion of mobile phase, using formic acid instead of glacial acetic acid and pre-treatment of fermentation broth,etc.,which impact the component C in gentamicin fermentation broth. Based on the result of above study,the following Waters-Nova-Pak system: Column: C18 4 pm 3. 9 × 150 mm Mobile phase system: 5. 0 g/L of heptane-sodium sulphonate methanol: water: formic acid=74: 21: 5 has been established and the sample analysis can been completed within 20 minutes. Furthermore good separation of peak C, and adjacent impurity peak has been obtained- It use formic acid instead of glacial aceticacid,which is described in pharmacopoeia,and better separation result has been obtaned. This provides anew effective way in quality control over gentamicin fermentation broth and in updating the qua1ity criteria.
出处
《海峡药学》
1999年第4期93-95,共3页
Strait Pharmaceutical Journal
关键词
HPLC
庆大霉素
发酵液
甲酸
质量控制
HPLC Gentamicin Fermentation broth formic acid Quality control
