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.
出处
《天津药学》
2008年第5期10-12,共3页
Tianjin Pharmacy
