高效液相色谱法测定甲硝唑芬布芬胶囊的含量

Determination of Metronidazole Fenbufen Capsules by High Performance Liquid Chromatography

目的:建立了甲硝唑芬布芬胶囊的含量测定方法,确立的色谱条件可同时检测出两种主要成分。方法:通过检测波长的确定、柱温的确定以及对流动相比例的调整等实验,对检测方法不断优化,最终色谱条件为:以AgilentSB-C18(4.6mm×250mm,5μm)为色谱柱,以甲醇-乙腈-水(25:55:20)(用磷酸调节pH值至3.0)为流动相,流速1.0mL·min^-1,检测波长:280nm,柱温:30℃,进样量:20μl。结果:经方法学验证实验,本法精密度好,在0.1~1.0mg·mL^-1范围内甲硝唑和芬布芬均呈良好的线性关系,且供试品在10h内稳定。结论:本研究为准确测定甲硝唑芬布芬胶囊的含量提供了方法依据。

Objective: This experiment establish content determination method of Metronidazole Fenbufen capsules, the chromatographic conditions established by this method can synchronously detect two main components. Method: The test method is continuously optimized through experiments such as the determination of the detection wavelength, the determination of the column temperature and the adjustment of ratio of mobile phaseand and the final chromatographic conditions are determined to be : chromatographic column is Agilent SB-C18(4.6mm×250mm,5μm), alcohol-acetonitrile-water (25:55:20)(pH is adjusted to 3.0 with phosphoric acid) is mobile phase, flow rate is 1.0mL·min -1 , detection wavelength is 280 nm, column temperature is 30℃, injection volume of sample is 20μl. Result: Through methodological verification experiment, the precision of this method is good, metronidazole and fenbufen showed a good linear relationship in the range of 0.1-1.0mg·mL^-1 and the test product was stable within 10h. Conclusion: This study provides methodological basis for accurately determine the content of metronidazole fenbufen capsules.