氟罗沙星葡萄糖注射液中氟罗沙星的含量测定

Determination of Fleroxacin in Fleroxacin and Glucose Injection by RP-HPLC

目的:建立氟罗沙星葡萄糖注射液中氟罗沙星含量的测定方法,为制剂的质量控制提供有效的分析手段。方法:采用高效液相色谱法,以Lichrospher-C18柱(200mm×4.6mm,5μm)为色谱分析柱,乙腈-0.015mol/L用磷酸调pH值至4.50的三乙胺水溶液(24∶76)为流动相,流速为1.0mL/min,紫外检测波长为286nm,采用外标法计算氟罗沙星含量。结果:建立的色谱方法使杂质与主药分离良好,氟罗沙星浓度在4.180～41.80μg/mL内与峰面积线性关系良好,平均回收率为99.43%,RSD为0.42%。结论:反相高效液相色谱法专属性强,操作方便,结果准确,重现性好。

Objective:To establish a HPLC method for determination of fleroxacin in fleroxacin and glucose injection.Methods:Reversed phase chromatographic separation was carried out on a Lichrospher-C18(200 mm×4.6 mm,5 μm).The mobile phase was constituted by acetonitrile-0.015 mol/L triethylamine solution (its pH was adjusted to 4.50 with phosphoric acid)(24 ∶76).The flow rate was 1.0 mL/min. The detection was carried out by using ultraviolet detector at 286 nm.The quantitative determination of fleroxacin was performed with external standard method.Results:Under optimal chromatographic conditions,the impurity and fleroxacin were completely separated.A good linearity was observed for fleroxacin in the range of 4.180～41.80 μg/mL.The average recovery of fleroxacin was 99.43%with RSD 0.42%. Conclusion:RP-HPLC is accurate,simple and reproducible and highly selective.