HPLC法测定注射用乳糖酸红霉素中的有关物质

Determination of Related Substances of Erythromycin Lactobionate for Injection by HPLC

目的建立HPLC法测定注射用乳糖酸红霉素有关物质的方法。方法采用资生堂CAPCELLMGC18色谱柱,流动相为磷酸盐溶液(取磷酸氢二钾8.7g,加水1000mL,用20%磷酸调节pH值至8.2)-乙腈(40∶60)。流速:1.0mL.min-1;柱温:35℃;检测波长:215nm。结果乳糖酸红霉素与其杂质(红霉素B、红霉素C,杂质1、红霉素烯醇醚)能达到基线分离;乳糖酸对有关物质的测定无影响;方法的专属性试验、最低检测限、耐用性试验、溶液的稳定性试验均可行。结论修订后的质量标准,可有效控制产品的质量。

Objective To establish a HPLC method for determination of related substances of Erythromycin Lactobionate for Injection. Methods A HPLC system was equipped with a CAPCELL C18 MG column,using phosphate buffer to dissolve （dipotassium Hydrogen Phosphate 8.7g diluting to 1000mL with water,adjusted to pH 8.2 with phosphoric acid）-acetonitrile （40：60）as mobile phase. Flow rate was 1.0mL·min^-1 at 35℃. The detective wavelength was 215nm. Results Erythromycin lactobionate and its related substances,including erythromycin B,erythromycin C,impurity 1 and erythromycin A enol ether,could be well separated from each other on the developed system. Lactobionate acid did not interfere with determination of the related substances. After specificity experiment,the limit of detection experiment,durability experiment and liquid stability experiment,the method was proved to be feasible. Conclusion The revised quality standard has obvious improvement in efficacy and controllability. It can be used to control the quality of product effectively.