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目的采用HPLC测定替加氟的含量及其有关物质。方法色谱柱为惠普C18柱(250mm×4.6mm,5μm),流动相为甲醇-乙腈-水(10:5:85),流速为1.0mL·min-1,检测波长为271nm。结果标准曲线的线性范围为0.537～214.8μg·mL-1(r=0.9999);替加氟的检测限和定量限分别为0.33、1.1ng;替加氟与其降解产物氟尿嘧啶的分离度为5.9,与酸、碱、光照、氧化、高温降解产物也有良好的分离。结论所用方法简便、准确、灵敏,可用于替加氟的常规分析。
Objective To determine the content of tegafur and its related substances by HPLC. Methods The column was HP C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-acetonitrile-water (10: 5: 85) with a flow rate of 1.0 mL · min-1 and a detection wavelength of 271 nm. Results The linear range of the standard curve was 0.537-214.8 μg · mL -1 (r = 0.9999). The detection limits and the limits of quantitation of tegafur were 0.33 and 1.1 ng, respectively. The separation of tegafur and its degradation product fluorouracil was 5.9, And acid, alkali, light, oxidation, high temperature degradation products also have a good separation. Conclusion The method is simple, accurate and sensitive and can be used for the routine analysis of Tegafur.