联苯双酯滴丸溶出度的测定与比较  

Determination and Comparation of the Dissolution of Bifendate Pills by HPLC

作　　者：杨永刚[1] 王震红[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药事》2010年第7期698-699,710,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立测定联苯双酯滴丸溶出度的方法 ,并进行了方法学研究。方法采用HPLC法,Kromasil C18柱,流动相为甲醇-水(70:30),检测波长为278nm,分别测定了不同生产厂家联苯双酯滴丸的溶出度。结果联苯双酯色谱峰分离度良好,线性范围为0.01234～0.1110μg(r=0.9998),平均回收率为99.28%,RSD=0.59%(n=9),不同生产厂家的联苯双酯滴丸的溶出度存在显著差异。结论所建方法简便、快速,专属性强,为制订联苯双酯滴丸溶出度方法提供依据。Objective To establish a method for determination of dissolution of bifendate in Bifendate Pills.Methods Using HPLC with Kromasil C18 column,methanol-water (70:30) as the mobile phase.The wavelength used for detection was 278nm.The dissolution of different brands of Bifendate Pills was investigated.Results The linear range was 2.074～18.670μg (r=1.000).The average recovery was 99.28% with RSD of 0.59%.The results showed the difference of dissolution of different brands was significant.Conclusion The method is simple and accurate.The study provides a quality evaluation method for Bifendate Pills.

关 键 词：HPLC 联苯双酯滴丸 溶出度 

分 类 号：R927.14[医药卫生—药学]