HPLC法测定盐酸沙拉沙星注射液含量_药物制剂.doc

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摘要 目的:建立高效液相色谱法测定沙拉沙星注射液中沙拉沙星的含量的方法。方法:采用Symmetry C18(250 mm×4.6 mm,5μm)色谱柱,以0.025mol/L磷酸溶液-乙腈(82∶18)为流动相(pH=3.0),流速1.0 ml/min,检测波长270nm。结果:沙拉沙星注射液在1-100μg/ml浓度范围内呈现良好的线性关系,相关系数R2为0.9994,平均回收率(n=6)为85.73%,RSD为4.64%。结论:该法准确、简便,适用于沙拉沙星注射液的含量测定。

关键词:沙拉沙星  注射液  含量测定  高效液相色谱法

 

Abstract objective:To establish an HPLC method for the determination of Sarafloxacin injection.  Methods:The analysis was carried on Symmetry C18 column (250 mm×4.6 mm, 5μm). The mobile phase was 0.025mol/L phosphoric acid in acetonitrile(82:18)(adjust to pH3.0);the detecting wavelength was 270 nm and flow rate 1.0 ml/min. Results:The range of Sarafloxacin was 1.0−100.0 μg/ml with r2=0.9994,showing very good linear relationship.The mean recovery was 85.73% and the relative standard deviation was 4.64%.Conclusion:The method is simple, accurate and can be used for the determination of Sarafloxacin infection. 

Key words:Sarafloxacin  infection  determination  HPLC