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：张树清 崔文奇[2] 王东凯[2] 张春叶[2] 高飞[2] 赵春晖[2] 肖玉婷[2] 殷栋二 韩贵成[2] 

机构地区：[1]辽宁省黑山县第二人民医院,121403 [2]沈阳药科大学 [3]海南碧凯药业

出　　处：《中国实用医药》2008年第6期46-47,共2页China Practical Medicine

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(4.6mm×250mm,5μm);流动相为乙腈-磷酸盐缓冲液(取磷酸二氢钾1.41g,磷酸氢二钾6.91g,加水至1000ml)-甲醇(44∶37∶19);柱温40℃;检测波长为205nm,流速2.0ml/min。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异构体的分离度不小于2.0;地红霉素16R异构体与9S红霉胺的分离度不小于5.0。结论本法简便、准确,具有可行性。Objective To establish a method to determine related substances in dirithromycin entericcoated pellets. Methods An HPLC method was used, DiamonsilTM column （5 μm 4.6 mm × 250 mm） was used. 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）as mobile phase;the detection wavelength was set at 205 nm ;flow rate 2 ml per minute and the column temperature at 40℃. Results Diritbromycin and its related substances could be separated well, the resolution, R, between dirithromycin （16R-epimer） and （16S-epimer） is no less than 2. 0, and between diritbromycin（16R-epimer） and 9-S-erytbromycylamine is no less than 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]