HPLC法测定氟胞嘧啶及其注射液中氟尿嘧啶有关物质___

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0.05 mol•L-1磷酸溶液调节pH至3.5)(5∶95)为流动相 流速为1.0 mL•min-1 检测波长为265 nm。结果：氟胞嘧啶浓度在1.2855~12.855 μg•mL-1范围内与峰面积线性关系良好,r=0.9998,氟尿嘧啶在0.26~2.56 μg•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0.98 ng，氟尿嘧啶检出限0.59 ng。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 establish HPLC method for determination of the related substances in flucytosine and flucytosine injection.Methods:The determination was carried out with a C18（4.6 mm×250 mm,5 μm）column,using methanol-water(adjust pH to 3.5 with 0.05 mol•L-1 phosphoric acid)(5∶95) as mobile phase,at a flow rate of 1.0 mL•min-1 and detected at the wavelength 265 nm.Results:The linear ranges of fluorouracil was 0.26-2.56 μg•mL-1(r=0.9996),and the detection limit was 0.1 ng.Conclusion:This method is simple,convenient.Compared with TLC,this method is can be applied for flucytosine injections quality control better.