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作 者:胡汉昆[1] 刘薇芝[1] 刘萍[1] 刘巍[1] 颜锵
机构地区:[1]武汉大学中南医院药学部,武汉430071 [2]武汉药谷科技开发有限公司
出 处:《中国药师》2012年第6期770-772,共3页China Pharmacist
基 金:湖北省计生委2011年度科研课题(编号:JS-2011003);国家"重大新药创制"科技重大专项课题(编号:2009ZX09301-014)
摘 要: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.
关 键 词:高效液相色谱法 硝酸布康唑阴道软胶囊 含量侧定
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