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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2~15μg·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。
Objective: To establish the best method for the determination of tegafur thermosensitive gel by high performance liquid chromatography. Methods: The HPLC method for determining the content of tegafur thermosensitive gel in Chinese Pharmacopoeia and reference was compared, and the detection conditions and sample processing methods were examined according to the characteristics of the gelling agent. The content of tebufenfluoride thermosensitive gel was determined. The recovery of each method Conduct a survey to make a comprehensive evaluation. RESULTS: Tegafur was linear in the range of 2-15 μg · ml-1 with a mobile phase of 0.02 mol·L-1 potassium dihydrogen phosphate-methanol (60:40) (r = 0.999 8 ), The average recovery was 99.71%, precision RSD less than 2%, in line with the requirements. The average content of tegafur in 3 batches of samples was (99.90 ± 0.78)% of the labeled amount. Conclusion: The method is simple, rapid, accurate and reproducible. It can provide the basis for quality control of tegafur thermosensitive gels.