HPLC法分析可利霉素的组分

Determination of the components of bitespiramycin by HPLC

可利霉素（kelimycin）又称必特螺旋霉素（bitespiramycin）、生技霉素（shengjimycin）是利用基因工程技术将碳霉素4″-异戊酰转移酶（4″-O-acyl-transferase）基因克隆到螺旋霉素产生菌中，

The paper is to report the establishment of an HPLC method for determination of the components of bitespiramycin and its products,and to evaluate the components profile of bitespiramycin and its related products.Liquid chromatography combined with mass spectrometry（LC-MS） was used to identify the nine major components of the reference substance of bitespiramycins.The nine components of bitespiramycins and its products have been quantified by HPLC with gradients elution methods.The content of the component of 4″-O-isovalerylspiramycin Ⅲ was not less than 35%,the content of the components of 4″-O-isovalerylspiramycin（Ⅰ ＋ Ⅱ ＋ Ⅲ） was not less than 60%,and the contents of the nine components of bitespiramycin were not less than 80%,separately.In addition to the components mentioned above,there also exists some other impurities,however,with lower contents.This gradient elution HPLC method reported by this paper is considered to be suitable for the quality control of bitespiramycin.