目的 建立高效液相色谱法标定左氧氟沙星杂质A对照品的含量.方法 色谱柱采用十八烷基硅烷键和硅胶为填充剂,流动相为醋酸铵高氯酸钠溶液:乙睛(55:45),流速为1.0mL/min;检测波长238nm,柱温:40℃.结果 杂质A进样量为0.84～3.38μg时与峰面积呈良好线性关系(r=0.9996),低检出量为0.2μg,重复性试验的RSD(n=6)为0.58%.结论 该方法准确、灵敏、可靠,专属性强,可用于左氧氟沙星杂质A的含量测定.%Objective To establish a method for the determination of levofloxacin impurity A(RS) by HPLC.Methods Analysis was carried out on a C18 column with ammonium acetate and sodium perchlorate solutionacetonitrile(55:45) as mobile phase.The flow rate is about 1.0mL per minute and UV detection wavelength was 238nm, the column temperature was 40℃.Results The line rage of impurity A was 0.84～3.38μg (r=0.9996).The limit of detection(LOD) was 0.2μg and the relative standard deviation (n=6) of reproducibility was 0.58％.Conclusion This method is accurate, specific, sensitive and can be used for the determination of levofloxacin impurity A.
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