摘要
Abstract
Objective To establish the determination method of the related substances in azithromycin lactobionate and its injection.Methods High performance liquid chromatography(HPLC)was used for the determination of the known impurity and the unknown impurities. The analysis was performed on a BDS HYPERSIL C18 column (250mm×4.6mm, 5μm). The mobile phase was composed of acetonitrile∶pH8. 2 phosphate buffer (0.05mol/L K2HPO4 solution, adjust pH to 8.2 with 20% phosphate acid) ( 55∶45) ,the injection amounts of sample solutions were 200μg,with the flow of 1.5mL/min.The detection wavelength was 293nm. ResultsAzithromycin lactobionate and its related substances can be well separated from each other on the developed system. The co-existence acids in azithromycin for injection did not interfere with the determination of the related substances. The chromatographic peak area and concentration of moxacin hydrochloride showed a good linear relationship.Accuracy and sensitivity of the method could meet the specific analytical requirements.Conclusion The developed method is convenient, a good specificity, high sensitivity. It can be used to determine the related substances in azithromycin lactobionate and its injection.关键词
高效液相色谱法/乳糖酸阿奇霉素/有关物质/制剂Key words
HPLC/Azithromycin lactobionate/Related substances/Drug products分类
医药卫生
