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中国药物评价 ›› 2020, Vol. 37 ›› Issue (4): 262-264.

• 评价技术与方法 • 上一篇    下一篇

HPLC法测定呋喃唑酮国家标准物质含量及有关物质

 杨青, 田冶#, 刘颖*, 尹利辉*   

  1. 中国食品药品检定研究院, 北京 100050
  • 收稿日期:2020-06-29 修回日期:2020-07-21 出版日期:2020-08-28 发布日期:2020-09-21

Determination Furazolidone and its Related Substances in National Reference Standard by HPLC Method

  1. National Institutes for Food and Drug Control, Beijing 100050, China
  • Received:2020-06-29 Revised:2020-07-21 Online:2020-08-28 Published:2020-09-21

摘要: 目的:建立高效液相色谱法测定呋喃唑酮国家标准物质含量及有关物质。方法:色谱柱:Shiseido CAPCELL PAK C18 MG Ⅱ(4.6 mm×250 mm,5 μm);流动相:水-甲醇;梯度洗脱;流速:1 mL·min-1;柱温:30 ℃;含量测定波长365 nm;有关物质采用303 nm和365 nm双波长检测。结果:呋喃唑酮与主要杂质5-硝基糠醛二乙酸酯之间以及各杂质之间分离度较好。呋喃唑酮在1~200 μg·mL-1、5-硝基糠醛二乙酸酯在0.1~2 μg·mL-1范围内线性关系良好。结论:该方法简单、准确、专属性好,重复性好,可用于呋喃唑酮国家标准物质含量及有关物质的测定。

关键词: font-size:medium, ">国家标准物质;呋喃唑酮;高效液相色谱法;含量;有关物质

Abstract: Objective: To develop a HPLC method for determination furazolidone and its related substances in national reference standard. Methods: The HPLC analysis was carried out on CAPCELL PAK C18 MG Ⅱ column(4.6 mm×250 mm,5 μm). The mobile phase consisted of water-methanol, and the flow rate was 1.0 mL·min-1, the temperature was 30 ℃. The detection wavelength of content determination was 365 nm. The detection wavelength of related substances determination was 303 nm and 365 nm. Results: The resolutions between furazolidone and the main impurity 5-nitrofurfural diacetate and other impurities were good. The liner range of furazolidone was 1-200 μg·mL-1 and 5-nitrofurfural diacetate was 0.1-2 μg·mL-1, respectively. Conclusion: The present method is simple, accurate, specific, reproducible, and can be used for the determination of furazolidone and related substances in furazolidone national reference standard. 
 

Key words: font-size:medium, ">National reference standard; Furazolidone; High performance liquid chromatography(HPLC); Content; Related substances

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