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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 a method for the determination of buconazole nitrate vaginal soft capsules by high performance liquid chromatography. METHODS: Hypersil C18 column (250 mm × 4.6 mm, 5 μm) and methanol-phosphate buffer (85:15) were used as the mobile phase. The detection wavelength was 229 nm. The number of theoretical plates according to Butoconazole peak calculation of not less than 2 000. Results: Butoconazole nitrate had a good linear relationship in the range of 0.41 ~ 4.12 μg (r = 0.999 4, n = 5) with an average recovery of 99.37% and a RSD of 0.74% (n = 9). Conclusion: The method is highly specific and reproducible. It can be used for the determination of buconazole nitrate vaginal soft capsules.