HPLC法测定硝酸布康唑阴道软胶囊的含量

Content Determination of Butoconazole Nitrate Vaginal Soft Capsules by HPLC

目的:建立高效液相色谱法测定硝酸布康唑阴道软胶囊的含量测定方法。方法:采用Hypersil C18色谱柱(250 mm×4.6 mm,5μm),甲醇-磷酸盐缓冲液(85∶15)为流动相;检测波长为229 nm。理论板数按布康唑峰计算不低于2 000。结果:硝酸布康唑在0.41～4.12μg范围内呈良好线性关系r=0.999 4(n=5),平均回收率99.37%,RSD=0.74%(n=9)。结论:该法专属性强,重复性好,可用于硝酸布康唑阴道软胶囊的含量测定。

Objective： To establish the method for the content determination of butoconazole nitrate vaginal soft capsules by HPLC. Method： An HPLC method was applied using a Hypersil C18 column （250 mm×4.6 mm,5 μm） , methanol-phosphate buffer solution （including potassium dihydrogen phosphate 4.18 g and dipotassium hydrogen phosphate 2.18 g, dissolved and diluted to 1 000 ml by water） （85：15 ） was the mobile phase, the UV detection wavelength was 229 nm, and the theoretical plates number was no less than 2 000. Result： The butoconazole nitrate showed a good linear relationship within the range of 0.41-4.12 μg ,r = 0. 999 4（ n = 5 ） , the average recovery was 99.37% with RSD of 0.74% （ n = 9） . Conclusion ： The method is highly specific and reproducible, and can be used to determine the content of butoconazole nitrate vaginal soft capsules.