红霉素眼膏有关物质的测定

Determination of Related Substances in Erythromycin Ophthalmic Ointment

目的:建立测定红霉素眼膏中有关物质的测定方法。方法:建立并优化提取方法采用高效液相色谱梯度洗脱法测定红霉素眼膏的有关物质。结果:采用pH 7.0磷酸盐缓冲液(PBS)-甲醇(1:1)进行一步萃取提取效果较好;经过方法学验证试验,该方法可用于测定红霉素眼膏的有关物质。结论:建立的方法可为红霉素眼膏质量控制提供较好的分析方法。

Objective： To establish a method for the determination of related substances in erythromycin ophthalmic ointment. Methods： The extraction method was established and optimized. An HPLC gradient elution method was used for the determination of related substances in erythromycin ophthalmic ointment. Results： One step extraction with PBS （ pH 7.0） - methanol （ 1 ： 1 ） had promising effect. After the method validation, it was proved that the method could be used to determine the related substances in eryth- romyein ophthalmic ointment. Conclusion： The method established in the paper provides a better analytical extraction and determina- tion method for the quality control of erythromycin ophthalmic ointment.