HPLC测定盐酸布替萘芬乳膏中有关物质的含量  

Determination of Related Substances in Butenafine Hydrochloride Cream by HPLC

作　　者：韩保萍 韩文芳 白若婉 闫国栋 孙春霞 

机构地区：[1]山东博士伦福瑞达制药有限公司,山东济南250101

出　　处：《食品与药品》2014年第6期435-438,共4页Food and Drug

摘　　要：目的建立HPLC测定盐酸布替萘芬乳膏中布替萘芬有关物质的方法。方法以十八烷基键合硅胶为填充剂,流动相为醋酸盐缓冲液-甲醇-异丙醇（17∶70∶13）,检测波长282 nm,流速1.0 m L/min。结果布替萘芬有关物质在0.625~5.000μg/m L范围内呈良好的线性关系（r=0.9989）,检出限2.6 ng。结论该方法分离效果好,灵敏高,重复性好,可用于盐酸布替萘芬有关物质的含量测定。Objective To determine the related substances in Butenafine Hydrochloride Cream. Methods A C18 column was used with the mobile phase of acetate buffer-methanol-isopropanol（17∶70∶13）.The detection wavelength was 282 nm. The flow rate was 1.0 m L/min. Results The calibration curve was linear in the range of 0.625~5.000 μg/m L for butenafine hydrochloride（r = 0.9989）. The detection limit was 2.6 ng. Conclusion The method is good in the aspects of separation, sensitivity and repeatability, and can be used for the quality control of related substances of butenafine hydrochloride.

关 键 词：盐酸布替萘芬乳膏 盐酸布替萘芬 高效液相色谱法 有关物质 

分 类 号：R927.11[医药卫生—药学]