HPLC测定盐酸四氢唑啉滴眼液的含量及其有关物质  

Determination of Tetrahydrozoline Hydrochloride and Its Related Substances in Eye Drops By HPLC

作　　者：税庆华 韩保萍 王玉玲 张世磊 于盛茂[2] 

机构地区：[1]山东博士伦福瑞达制药有限公司,济南250014 [2]山东省生物药物研究院,济南250014

出　　处：《中国药学杂志》2008年第19期1513-1515,共3页Chinese Pharmaceutical Journal

摘　　要：目的建立HPLC测定盐酸四氢唑啉滴眼液含量的方法。方法采用Diamonsil C18(4.6mm×150mm,5μm)色谱柱;以甲醇-醋酸盐缓冲液(40:60)为流动相,检测波长为235nm。结果盐酸四氢唑啉质量浓度在9.94～497.0mg.L-1内与峰面积呈良好线性关系(r=0.9999);最低检测限为0.22ng;平均回收率为99.86%,RSD为0.23%。结论本方法灵敏度高,方法操作简便,可满足本品含量及有关物质的测定。OBJECTIVE To establish a HPLC method for determining the content of tetrahydrozoline hydrochloride and its related substances in eye drops. METHODS A diamonsil C18 column （4.6mm×150mm,5um） was used with a mobile phase of methanolacetate buffer （40： 60） . The detection was carried out at 235 nm. RESULTS The determination limit was 0. ：22 ng. The standard curve was linear in the range of 9.94 - 497.0 mg·L^-1 （r = 0. 999 9）. The average recovery was 99.86% and RSD was 0. 23% . CONCLUSION The method established is successfully used to determine tetrahydrozoline hydrochloride and its related substances in eye drops.

关 键 词：盐酸四氢唑啉滴眼液 含量测定 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]