琥乙红霉素片含量的微生物检定与HPLC法分析比较

Analysis of determination of microbial titer and HPLC content of erythromycin Ethylsuccinate Tablets

目的:比较琥乙红霉素片含量的HPLC法与抗生素微生物检定法有无差异确定哪种方法更适合做质量标准。方法:采用HPLC法和微生物法测定3批药品的含量。结果:将上述两种结果进行分析,发现两种方法差异无显著性,HPLC法测定较为简便。结论:建议使用HPLC法作为琥乙红霉素片含量的质量标准。

Content determination of erythromycin Ethylsuccinate tablets at present standard microbiological assay method. In this paper,the comparison of erythromycin Ethylsuccinate Tablets by HPLC method and microbiological assay has no differences and which method is more suitable for quality standards.Methods： the contents of 3 batches of drugs were determined by HPLC method and microbiological method.Results： the above two results were analyzed,and the difference between the two methods was not significant,and the HPLC method was simple and easy to be determined.Conclusion： it is recommended to use HPLC as a method for the determination of the quality standard content of erythromycin Ethylsuccinate tablets.