摘要
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（5μm,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1.0mL·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 was30 ℃. 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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2014年第8期1509-1512,共4页
Chinese Journal of Pharmaceutical Analysis
