富马酸酮替芬片溶出度的测定

Dissolution Determination of Ketotifen Fumarate Tablets

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 mL为溶出介质，转速50 r·min^-1，Inertsil ODS-SP色谱柱(4.6 mm×250 mm，5 μm)，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0.1~25 μg·mL^-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。

Abstract: OBJECTIVE To establish an HPLC method for the determination of the dissolution of Ketotifen Fumarate tablets. METHODS The paddle method was used with 900 mL 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·mL^-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.