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目的:建立测定复方氟尿嘧啶注射液含量及其有关物质的HPLC法。方法:采用C_(18)色谱柱,以水(0.05 mol·L~(-1)磷酸溶液调节pH至3.5)-甲醇(95:5)为流动相,检测波长为265 nm。结果:氟尿嘧啶与其相邻杂质峰能完全分离,在进样量0.038 92～1.946μg范围内与峰面积线性关系良好(r=0.999 9,n=6),平均回收率为99.2%(RSD=0.5%);最低检出量为0.8 ng。结论:本法专属准确,可用于复方氟尿嘧啶注射液的质量控制。
Objective: To establish a HPLC method for the determination of compound fluorouracil injection and its related substances. Methods: The mobile phase was C_ (18) column with water (0.05 mol·L -1 phosphoric acid solution) adjusted to pH 3.5 and methanol (95: 5). The detection wavelength was at 265 nm. Results: Fluorouracil was completely separated from the adjacent impurity peak. The linear relationship was good (r = 0.999 9, n = 6) and the average recovery was 99.2% (RSD = 0.5) in the range of 0.038 92-1.946 μg %); The minimum detectable amount is 0.8 ng. Conclusion: This method is accurate and accurate and can be used for the quality control of compound fluorouracil injection.