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反相高效液相色谱法测定巴洛沙星片的含量及有关物质 被引量:4

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