HPLC法测定西他沙星异构体  

HPLC determination of sitafloxacin in the isomer

作　　者：张秋佳 陈雷 邹德超 张猛 

机构地区：[1]北京科莱博医药开发有限责任公司(国家新药开发工程技术研究中心),北京102600

出　　处：《中国抗生素杂志》2012年第3期237-239,I0003,共4页Chinese Journal of Antibiotics

摘　　要：目的研究西他沙星中异构体的检测方法。方法采用HPLC法，以十八烷基键合硅胶柱（2．1mm×50mm，2．7μm）为色谱柱，（CuSO4 1g、D-苯丙氨酸1．32g、加水溶解并定容至1000mL，用氢氧化钠调节pH至3．5）-甲醇（80：20）混匀为流动相，流速0．5mL／min，检测波长295nm，柱温：40℃。结果异构体A浓度在0．004136-0．02068mg／mL范围内呈良好线性关系，r=0．9999；异构体B浓度在0．00404-0．0202mg／mL范围内呈良好线性关系，r=0．9996；西他沙星浓度在0．004096-0．02048mg／mL范围内呈良好线性关系，r=0．9997。结论所建立方法简便、快速、准确度高、专属性强、重现性良好，适宜于西他沙星异构体检测。Objective Sitafloxacin isomers in the detection method. Methods The HPLC was conducted on a octadecyl silica gel column （2.1mm-50mm, 2.7μm） with （CuSO4 lg, D-Phenylalanine 1.32g, dissolved in water and set the volume to 1000mL, with sodium hydroxide adjust the pH to 3.5）- methanol （80： 20） mix as mobile phase, flow rate 0.SmL/min, detection at 295nm, column temperature： 40℃. Results The calibration curve was linear within the range of 0.004136-0.02068mg/mL （r=0.9999） for isomer A; the calibration curve was linear within the range of 0.00404-0.0202mg/mL （r=0.9996） for isomer B; the calibration curve was linear within the range of 0.004096-0.02048mg/mL （r=0.9997） for sitafloxacin. Conclusion The method is simple, fast, accurate, specific, good reproducibility, suitable for sitafloxacin isomer detection.

关 键 词：西他沙星 高效液相色谱 异构体 

分 类 号：R927.11[医药卫生—药学]