氟尿嘧啶清洁验证残留量测定方法的研究

Determining the residues content of Fluorouracil on cleanning validation

目的建立生产系统中氟尿嘧啶清洁后残留量的测定方法,保证氟尿嘧啶残留量达到允许的范围,降低对其他产品造成污染的风险。方法采用高效液相色谱法Symmetry shield TMRPC18柱(4.6×150 mm,5μm),以甲醇-水(10:90)为流动相,检测波长为265nm,流速为1.0 ml/min。结果氟尿嘧啶残留在0.10μg/ml～0.7μg/ml之间,峰面积与量呈线性关系(r=0.9999)。平均回收率为99.1%。结论本法具有专属、可靠、灵敏度高、干扰小等特点,可作为氟尿嘧啶清洁后残留量的测定方法。

Objective To set up a method for determination of the content of Fluorouracil on cleanning validation to Assuring the residues content of Fluorouracil being in allowing range, and to reduce the risk of polluting other product. Methods HPLC method was used. The sample was separated by Symmetry shield TM RP C18 column（ 4. 6 x 150 mm ,Sum）. The mobile phase was methanol-water（10：90）. The detection wavelength was 265 nm. Flow rate was 1.0 mE/rain. Results When the residues content of Fluorouraci] were between 0. 10 μgg/ml and 0. 7 μgg/ml,the peak area and content was linear （r =0. 9999）. The Average recover rate was 99.1%. Conclusion The method is technical, credibility, sensitive. It can be a method for determining the residues content of Fluorouracil on cleanning validation.