反相高效液相色谱法测定巴洛沙星片的含量及有关物质  

Determination and its related substances of balofloxacin tablets by RP-HPLC

作　　者：米亚娴[1] 吴燕[1] 李华龙[1] 李立俭[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《天津药学》2008年第5期10-12,共3页Tianjin Pharmacy

摘　　要：目的：建立巴洛沙星片含量及有关物质测定的反相高效液相色谱方法。方法：色谱柱为Diamonsil^TM C18（4．6mm×250mm，5μm）；流动相为乙腈-0．05mol／L柠檬酸（用三乙胺调pH4．0）（22：78），检测波长294nm。结果：在0．52～83．2μg/ml范围内，溶液浓度与峰面积呈良好的线性关系，平均回收率为99．6％，RSD为0．55％（n=9）。结论：该方法简单、快速、准确，重现性及专属性好，可用于巴洛沙星片的质量控制。OBJECTIVE To establish an HPLC method for determination and its related substances of balofloxacin tablets by RP-HPLC. METHODS The column was Diamonsil^TM C18 （4.6 mm×250 mm,5μm） and acetonitrile - 0.05 mol/L citric acid （adjusted pH to 4.0 with triethylamine ） （22：78） used as the mobile phase. The detecting wavelength was set at 294 nm. RESULTS There was a good linear relationship between the concentration of balofloxacin and the areas in the range of 0.52-83.2 μg/ml. The average recovery was 99.6% with RSD of 0.55% （n=9）. CONCLUSION This method is simple, rapid, accurate and reproducible. It can be used as the quality control for balofloxacin tablets.

关 键 词：高效液相色谱法 巴洛沙星片 含量测定 有关物质测定 

分 类 号：R927.2[医药卫生—药学]