替加氟温敏凝胶含量测定方法的建立

目的:建立以高效液相色谱法测定替加氟温敏凝胶含量的最佳方法。方法:通过对中国药典和参考文献中测定替加氟温敏凝胶含量的HPLC方法进行比较,并根据凝胶剂特点考察检测条件、样品处理方法,测定替加氟温敏凝胶含量,对各方法回收率进行考察,做出综合评价。 结果:在流动相为:0.02 mol·L^-1磷酸二氢钾溶液-甲醇(60:40)的条件下,替加氟在2~15 μg·ml^-1范围内线性关系良好(r=0.999 8),平均加样回收率为99.71%,精密度RSD低于2%,符合要求。3批样品中替加氟的平均含量为标示量的(99.90±0.78)%。结论:本检测方法简便、快速、结果准确、重复性好,可为替加氟温敏凝胶的质量控制提供分析依据。

Establishment of determination method of tegafur content in tegafur thermosensitive hydrogels by HPLC

OBJECTIVE To establish an HPLC optimal method for determination of tegafur content in tegafur thermosensitive hydrogels. METHODS The HPLC methods of content determination for tegafur thermosensitive hydrogels in the National Formulary and references were compared. The testing conditions and sample preparation methods were surveyed according to the features of gel, content of tegafur thermosensitive hydrogels was determined, various methods for recovery were inspected, and a comprehensive evaluation was performed.RESULTS By using mobile phase of 0.02 mol·L^-1potassium dihydrogen phosphate solution and methanol (60:40), the linear relationship of tegafur was good in the concentration range of 2-15 μg·ml^-1 (r=0.999 8), which met the requirements, and the average contents of tegatur in three batches of samples was (99.90±0.78)% (n=3). CONCLUSION It is a simple, accurate, fast and reproducible method for quality control of tegafur thermosensitive hydrogels.