HPLC法测定尿嘧啶替加氟片含量

Assay of Uracil-tegafur Tablets by HPLC

目的采用HPLC法测定尿嘧啶替加氟片的含量。方法 Agilent1200 HPLC仪;Agilent ZOBAX C18色谱柱(150 mm×4.6 mm,5μm);流动相:甲醇-水(10∶90);流速:1.0 ml/min;柱温:30℃;检测波长:271 nm。结果尿嘧啶、替加氟分别在0.16～1.60μg、0.08～0.80μg范围内线性关系良好(r=0.9999、r=0.9995),平均加样回收率分别为99.53%、100.68%,RSD分别为0.74%、1.63%(n=6)。结论本方法简便、准确、重复性好,为完善本产品质量控制提供依据。

Objective To assay the compound tegafur tablets by HPLC. Methods The column of C18 （ 150 mm×4.6 mm,5 μm） was used. The mobile phase consisted of methanol-water（ 10： 90） at a flow rate of 1.0 ml/min,a column temperature of 30 ℃ ,and a detection wavelength of 271 nm. Results For uracil,the standard curve yielded a good lineari- ty（ r =0. 9999） within the range of0. 08-0.80 μg,and the average recovery of standard addition reached 99.53% （RSD 0.74%, n =6）. For tegafur,the standard curve also yielded a good linearity（ r =0.9995） within the range of 0. 16-1.60 μg,and the average recovery of standard addition was 100.68% （RSD 1.63%, n =6）. Conclusion This method is sim- ple,accurate and repeatable,it can be an alternative to the assay of similar products.