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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,5μm),流动相为水-乙腈,梯度洗脱[0 min(90%水)→10 min(50%水)→20 min(95%水)→30min(95%水)→35 min(90%水)],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0.2516～3.744μg.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 the determination of 5-nitrofurfural diacetate and other related substances in furazolidone. Methods: Alltima C18 column (150 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of water and acetonitrile with gradient elution [0 min (90% water) → 10 min (50% Water) → 20 min (95% water) → 30 min (95% water → 35 min (90% water)] at a flow rate of 1.0 mL · min-1 with a detection wavelength of 303 nm (5-nitrofurfural diacetate ) And 210 nm (other related substances). Results: Both furazolidone and 5-nitrofurfural diacetate and their degradation products were separated well; the linear range of 5-nitrofurfural diacetate was 0.2516 ~ 3.744μg.mL-1, the average recovery was n = 9) was 100.7%. The minimum detectable levels of furazolidone and 5-nitrofurfural diacetate were 1.53 ng and 0.20 ng, respectively. The test solution was stable within at least 8 h. Conclusion: This method is specific, easy to operate, accurate, sensitive and can be used as a quality control method for furazolidone.