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| HPLC法测定地红霉素肠溶微丸的有关物质 | |
| 引用本文： | 张树清,崔文奇,王东凯,张春叶,高飞,赵春晖,肖玉婷,殷栋二,韩贵成. HPLC法测定地红霉素肠溶微丸的有关物质[J]. 中国实用医药, 2008, 3(6): 46-47 |
| 作者姓名： | 张树清 崔文奇 王东凯 张春叶 高飞 赵春晖 肖玉婷 殷栋二 韩贵成 |
| 作者单位： | 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 |
| 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。 |
| 关 键 词： | 高效液相色谱法 地红霉素肠溶微丸 有关物质 |
HPLC determination of related substances in dirithromycin enteric-coated pellets |
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| ZHANG Shu-qing,CUI Wen-qi,WANG Dong-kai,et al.. HPLC determination of related substances in dirithromycin enteric-coated pellets[J]. China Practical Medical, 2008, 3(6): 46-47 | |
| Authors: | ZHANG Shu-qing CUI Wen-qi WANG Dong-kai et al. |
| Affiliation: | ZHANG Shu-qing,CUI Wen-qi,WANG Dong-kai,et al.School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China |
| Abstract: | 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. |
| Keywords: | HPLC Dirithromycin enteric-coated pellets Related substances |
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