RP-HPLC测定盐酸特比萘芬含量及有关物质  

RP- HPLC determination of terbinafine hydrochloride and its related substances

作　　者：刘红菊[1] 蒋晔[1] 郝晓花[1] 

机构地区：[1]河北医科大学药学院,石家庄050017

出　　处：《药物分析杂志》2006年第9期1302-1304,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立盐酸特比萘芬及其有关物质的反相高效液相色谱测定方法。方法:采用C_(18)色谱柱(250mm×4.6mm,5μm),以甲醇为流动相,流速1.0mL·min^(-1),检测波长282nm。结果:盐酸特比萘芬浓度在5.7×10^(-3)～1.15mg·mL^(-1)时与峰面积线性关系良好(r=0.9999)。平均回收率为99.8%,RSD<0.86%。结论:本方法简便,快速,准确,可用于盐酸特比萘芬原料及其制剂的含量测定及有关物质检查。Objective ： To establish a RP - HPLC method for the analysis of terbinafine hydrochloride and its related substances. Method：A C18 column（250 mm×4.6 mm,5 μm） was used with the mobile phase of methanol. The flow rate was 1.0 mL min^-1 and the detection wavelength was 282 nm. Results：The calibration curves were linear between 5.7×10^-3-1.15 mg ·mL^-1 （r =0. 999 9）. The average recovery was 99.8% ,RSD 〈0. 86%. Conclusion： The method is simple, rapid and suitable for determination of the content and the related substances of terbinaline hydrochloride and its preparation.

关 键 词：盐酸特比萘芬 盐酸特比萘芬乳膏 反相高效液相色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学]