HPLC法测定地红霉素肠溶微丸的有关物质  

HPLC determination of related substances in dirithromycin enteric-coated pellets

作　　者：戴玉荣[1] 成海平[2] 崔文奇[3] 王东凯[3] 殷栋二 

机构地区：[1]中日友好医院,北京100029 [2]国家食品药品监督管理局药品审评中心,北京100038 [3]沈阳药科大学药学院,沈阳110016 [4]海南碧凯药业,海口570216

出　　处：《中国新药杂志》2008年第14期1252-1253,1260,共3页Chinese Journal of New Drugs

摘　　要：目的:测定地红霉素肠溶微丸的有关物质。方法:采用HPLC法,色谱柱为DiamonsilTMC18(250 mm×4.6 mm,5μm);流动相为乙腈-磷酸盐缓冲液(取磷酸二氢钾1.41 g,磷酸氢二钾6.91 g,加水至1 000 mL)-甲醇(44∶37∶19);柱温40℃;检测波长为205 nm,流速2.0 mL.min-1。结果:此色谱条件下药物与降解产物能达有效分离,地红霉素16R异构体与地红霉素16S异构体的分离度≥2.0;地红霉素16R异构体与9(S)红霉胺的分离度≥5.0。结论:本法简便,准确,方法可行。Objective：To establish a method for determining related substances in dirithromycin enteric-coated pellets.Methods：The separation was performed on Diamonsil^TM column（250 mm×4.6 mm,5 μm） with the mobile phase consisting of acetonitrile-PBS（1.41 g monobasic potassium phosphate and 6.91 g of dibasic potassium phosphate in 1 liter of water）-methanol（44∶37∶19）.The detection wavelength was set at 205 nm.The flow rate was 2.0 mL per minute and the column temperature was at 40 ℃.Results：Dirithromycin and its related substances were separated well.The resolution（R） between dirithromycin（16R-epimer） and（16S-epimer） was not less than 2.0,and that between dirithromycin（16R-epimer） and 9-（S）-erythromycylamine was above 5.0.Conclusion：The method appeared to simple,accurate and reproducible.

关 键 词：高效液相色谱法 地红霉素肠溶微丸 有关物质 

分 类 号：R927.2[医药卫生—药学] R978.15