HPLC法测定盐酸特拉唑嗪胶囊溶出度  

Determination of the Dissolution of Terazosin Hydrochloride Capsule by HPLC

作　　者：郭小洁[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药品标准》2005年第2期8-11,共4页Drug Standards of China

摘　　要：目的:建立盐酸特拉唑嗪胶囊溶出度的高效液相色谱分析方法。方法:以C1 8(4.6×2 5 0 mm ,5μm )为色谱柱,甲醇-水-冰醋酸-三乙胺(5 0 0∶5 0 0∶10∶0 .3)为流动相,流速为1.0 ml·min- 1 ,检测波长为2 4 6 nm。结果:盐酸特拉唑嗪在0 .4～4 .0 μg·ml- 1的浓度范围内,呈现良好线性相关(r=0 .9995 ) ;平均回收率为99.5 % ,RSD为1.0 % (n=9) ;三批样品测定结果符合规定。结论:采用本法测定盐酸特拉唑嗪胶囊溶出度,空白辅料峰与盐酸特拉唑嗪峰良好分离,有效消除空白胶囊与辅料干扰,且具有专属性强,灵敏度高,准确度好,简便快速等特点。Objective:The HPLC method of determination of the dissolution of Terazosin Hydrochloride Capsule was described.Methods:The C 18 (4.6×250mm,5μm)column was used,the mobile phase was methanol-water-glacial acetic acid-triethylamine(500∶500∶10∶0.3),the flow rate was 1.0ml·min -1 ,the wavelength used for detection was 246nm.Results:The linear range of Terazosin Hydrochloride was 0.4～4.0μg·ml -1 (r=0.9995),the average recovery was 99.5%,RSD=1.0%(n=9),and the dissolutions of the samples were compiled with the quality standard.Conclusions:The method removed the interfere with the placebo and blank capsule effectively when the dissolution of Terazosin Hydrochloride capsule was determined.The method was accurate,reliable,rapid and convenient.It can be used as a reliable method of quality control for Terazosin Hydrochloride capsule.

关 键 词：HPLC法 盐酸特拉唑嗪胶囊 溶出度 高效液相色谱 回收率试验 

分 类 号：R914[医药卫生—药物化学]