HPLC法测定呋喃西林冲洗液的含量及有关物质

目的：应用HPLC建立测定呋喃西林冲洗液中呋喃西林含量及有关物质检查的方法。方法：采用依利特Hypersil ODS2色谱柱（5 μm，4.6 mm×150 mm），以0.2%三乙胺的水溶液（冰醋酸调节pH为4.0±0.5）-乙腈（80：20）为流动相，流速1.0 mL·min^-1，检测波长375 nm，柱温30 ℃。结果：方法的线性范围按呋喃西林记为0.0112~0.032 mg·mL^-1，r=0.9995；加样回收率（n=9）在96.9%~103.8%之间；呋喃西林的检测限为2.6 ng，定量限为 5.2 ng；呋喃西林的色谱峰与各相邻有关物质峰之间分离度均大于1.5。结论：经方法学验证，本法操作简便，准确，专属性好，可有效控制呋喃西林冲洗液的质量，既可用于含量测定，又可对有关物质进行检查。

Objective: To establish an HPLC determination method for contents of nitrofurazone flushing fluid and its related substances. Methods: Elite Hypersil ODS2 column (5 μm,4.6 mm×150 mm) was adopted;the mobile phase contained 0.2% triethylamine solution (pH was adjusted to 4.0±0.5 with glacial acetic acid)-acetonitrile (80:20) at a flow rate of 1.0 mL·min^-1;the detection wavelength was 375 nm,and the column temperature was 30 ℃. Results: The linear range of nitrofurazone was 0.0112-0.032 mg·mL^-1,r=0.9995.The recoveries of nitrofurazone(n=9) were between 96.9% and 103.8%.The detection limit and quantification limit of nitrofurazone were 2.6 and 5.2 ng,respectively.The resolution of the nitrofurazone peak with related substances peaks was above 1.5. Conclusion: The chromatographic conditions are suitable for the determination of both nitrofurazone and related substances.Furthermore,this method is simple,accurate and specific,and can effectively control the quality of the nitrofurazone flushing fluid.

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