梯度洗脱HPLC法双波长测定呋喃唑酮中的相关物质

目的: 建立测定呋喃唑酮中5-硝基糠醛二乙酸酯及其他相关物质的方法。 方法: 采用反相高效液相色谱法,色谱柱为Alltima C₁₈(150 mm×4.6 mm,5 μm),流动相为水-乙腈,梯度洗脱 ,流速1.0 mL·min^-1,检测波长为303 nm(5-硝基糠醛二乙酸酯)和210 nm(其他相关物质)。 结果: 呋喃唑酮与5-硝基糠醛二乙酸酯及其强制破坏产生的降解产物均分离良好;5-硝基糠醛二乙酸酯线性范围为0.2516~3.744 μg·mL^-1,平均回收率(n=9)为100.7%;呋喃唑酮和5-硝基糠醛二乙酸酯最低检测量分别为1.53 ng和0.20 ng;供试品溶液至少8 h内稳定。 结论: 本法专属性强,操作方便,测定准确,灵敏度高,可作为呋喃唑酮的质量控制方法。

Objective: To establish a method for determination of 5-nitro-2-furaldehyde diacetate and other related substances in furazolidone. Methods: An Alltima C₁₈ column(150 mm×4.6 mm,5 μm) was adopted. The mobile phase was water-acetonitrile with gradient elution ;5-nitro-2-furaldehyde diacetate and other related substances were determined with double UV wavelengths, which were 303 nm for 5-nitro-2-furaldehyde diacetate and 210 nm for other related substances. Results: The resolution between furazolidone peak and other peaks was good. The linear range of 5-nitro-2-furaldehyde diacetate was 0.2516-3.744 μg·mL^-1 and the average recovery(n=9) was 100.7%; The detection limits of furazolidone and 5-nitro-2-furaldehyde diacetate were 1.53 ng and 0.20 ng, respectively. The test solution was stable within 8 h. Conclusion: The method is specific, convenient, accurate, sensitive, and can be used for the quality control of furazolidone.