富马酸酮替芬片溶出度的测定  

Dissolution Determination of Ketotifen Fumarate Tablets

作　　者：秦斌[1,2] 谭志欣[3] 殷果[1,2] 周远波[4] 闫研[1,2] 

机构地区：[1]深圳药品质量标准研究重点实验室,广东深圳518057 [2]深圳市药品检验所,广东深圳518029 [3]广州市胸科医院,广州510095 [4]广东药学院,广东东莞523808

出　　处：《中国现代应用药学》2015年第1期72-75,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立富马酸酮替芬片溶出度测定方法。方法采用浆法,以水900 m L为溶出介质,转速50 r·min-1,Inertsil ODS-SP色谱柱（4.6 mm×250 mm,5μm）,以甲醇-水-三乙胺（950∶50∶0.02）为流动相,检测波长：300 nm。结果富马酸酮替芬的浓度在0.1~25μg·m L-1内与峰面积线性关系良好,回收率为99.9%,RSD为0.1%。结论该溶出度实验条件可以较客观地反映产品的内在品质,对不同来源的同一制剂具有显著的区分力。OBJECTIVE To establish an HPLC method for the determination of the dissolution of Ketotifen Fumarate tablets. METHODS The paddle method was used with 900 m L water as dissolution medium at the rotate speed of 50 r·min-1. Inertsil ODS-SP column（4.6 mm×250 mm, 5 μm） was used with the mobile phase of methanol-water-triehylamine（950∶50∶0.02） at the detection wavelength of 300 nm. RESULTS The calibration curve of ketotifen fumarate was linear in the ange of 0.1-25 μg·m L-1. The average recovery was 99.9% with RSD of 0.1%. CONCLUSION The inherent quality of the product can be objectively reflected in the above conditions. Furthermore, it has a significant distinction of the same agents from different sources.

关 键 词：富马酸酮替芬片 溶出度 浆法 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学]