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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 a method for the determination of ketotifen fumarate dissolution. Methods The aqueous medium with 900 m L of water and 50 r · min-1 of water was used as an eluting medium. The column was eluted with methanol-water-triethylamine (950:50, 4.6 mm × 250 mm, 5 μm) : 0.02) as mobile phase, detection wavelength: 300 nm. Results The concentration of ketotifen fumarate in the range of 0.1 ~ 25μg · m L-1 showed a good linear relationship with the peak area. The recovery rate was 99.9% and the RSD was 0.1%. Conclusion The experimental conditions of dissolution can objectively reflect the inherent quality of products, and have distinct distinguishing power for the same preparation from different sources.