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目的:用高效液相色谱法测定氟胞嘧啶及氟胞嘧啶注射液有关物质。方法:用十八烷基硅烷键合硅胶为填充剂,以甲醇-水(用0.05mol.L-1磷酸溶液调节pH至3.5)(5:95)为流动相;流速为1.0mL.min-1;检测波长为265nm。结果:氟胞嘧啶浓度在1.2855～12.855μg.mL-1范围内与峰面积线性关系良好,r=0.9998,氟尿嘧啶在0.26～2.56μg.mL-1浓度范围内与峰面积线性关系良好,r=0.9999,氟胞嘧啶检出限0.98ng,氟尿嘧啶检出限0.59ng。结论:该方法简便、准确,较TLC法更适于该品种的质量控制。
Objective: To determine the related substances of flucytosine and flucytosine injection by high performance liquid chromatography. METHODS: Octadecylsilane bonded silica gel was used as the mobile phase with methanol-water (pH = 3.5 with 0.05mol.L-1 phosphoric acid solution) (5:95) as the mobile phase. The flow rate was 1.0mL.min- 1; detection wavelength is 265nm. Results: The linear range of flucytosine in the range of 1.2855 ~ 12.855μg.mL-1 was linear with the peak area (r = 0.9998). The linear range of fluorouracil to peak area was 0.26 ~ 2.56μg.mL-1, r = 0.9999, detection limit of flucytosine 0.98ng, detection limit of fluorouracil 0.59ng. Conclusion: The method is simple and accurate, which is more suitable for quality control than TLC method.