高效毛细管电泳法测定氟尿嘧啶注射液中5-氟尿嘧啶的含量

Determination of the concentration of 5-fluorouracil in fluorouracil injection by high performance capillary electrophoresis(HPCE)

目的：建立高效毛细管电泳（HPEC）测定氟尿嘧啶注射液中氟尿嘧啶（5-FU）含量的方法。方法：运用高效毛细管电泳方法，熔融石英毛细管（50cm×57cm，75μm），缓冲液：10mmol·L^-1磷酸二氢钠（pH5．5），检测波长：280nm，分离电压：15kV，用微孔滤膜过滤后进样，压力进样：6s。结果：方法最低检测浓度为0．1mg·L^-1，线性范围5～200mg·L^-1，r=0．9990，线性关系良好。日内RSD为2．3％，日间RSD为2．7％，回收率为99．7％。结论：本法简单、灵敏经济，可作为氟尿嘧啶注射液中氟尿嘧啶的含量的测定方法。

OBJECTIVE A method for the determination of 5-fluorouracil in fluorouracil injection was established by high performance capillary electrophoresis （HPCE）. METHODS The separation conditions of HPCE were 10 mmol L^-1 sodium dihydrogen phosphate buffer as running buffer, UV detection was set at 280 nm, separation voltage was 15 kV, and pressure injection was 6 s. RESULTS The minimal quantitative concentration was 0. 1 mg·L^-1. The concentration of 5-fluorouracil showed a linear plot in the range of 5-200 mg·L^-1 （r = 0. 999 0）. The recovery was found to be 99.7%, Internal day and between-day variation were 2. 3% and 2. 7%, respectively. CONCLUSION The results of the experiments demonstrated that the established method is simple, sensitive and economic. The method is suitable for use in quality control of fluorouracil injection.