甲硝唑芬布芬胶囊中溶出度的测定方法研究

Study on dissolution determination method of Metronidazole and Fenbufen Capsules

目的建立高效液相色谱法测定甲硝唑芬布芬胶囊的溶出度试验方法。方法色谱柱为kromasil C18柱(4.6 mm×250 mm,5μm);流动相为甲醇:乙腈:水(40:60:40),用磷酸调节pH值至3.0;检测波长为295 nm。结果甲硝唑在10～50μg.ml-1范围内线性关系较好,r=0.999 9,回收率为98.3%,精密度(RSD)为0.82%;芬布芬在6～30μg.ml-1范围内线性关系较好,r=0.999 9,回收率为97.2%,RSD为0.78%。结论建立的高效液相色谱法简便、快速、准确,重复性好,可作为甲硝唑芬布芬胶囊溶出度的检测。

Objective To establish a HPLC method for detecting the dissolution of Metronidazole and Fenbufen Capsules.Methods The Kromasil C18 column（4.6 mm×250 mm,5 μm） was used,the mobile phase was methanol：acetonitrile：water（40：60：40,adjusting pH 3.0 with phosphoric acid）,the detection wavelength was 295 nm.Results The linear range of metronidazole was 10-50 μg·mL-1,the coefficient correlation r was 0.999 9,the average recovery rate of metronidazole was 98.3% with RSD 0.82%.The linear range of fenbufen was 6-30 μg·mL-1,the coefficient correlation r was 0.999 9,the average recovery rate of fenbufen was 97.2% with RSD 0.78%.Conclusion The method is simple,rapid and accurate with good reproducibility,which can be used for detecting the dissolution of Metronidazole and Fenbufen Capsules.