节点文献
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
【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C18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。
【Abstract】 Objective:To establish a RP-HPLC method for the analysis of terbinafine hydrochloride and its related substances.Method:A C lscolumn(250 mm×4.6 mm,5μm)was used with the mobile phase of methanol.The flow rate was 1.0 mL min-1and the detection wavelength was 282 nm.Results:The calibration curves were linear be- tween 5.7×10-3~1.15 mg·mL-1(r=0.9999).The average recovery was 99.8% ,RSD<0.86%.Conclu- sion:The method is simple,rapid and suitable for determination of the content and the related substances of terbin- afine hydrochloride and its preparation.
【Key words】 terbinafine hydrochloride; terbinafine hydrochloride cream; RP-HPLC; related substance;
- 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2006年09期
- 【分类号】R927
- 【被引频次】6
- 【下载频次】254