HPLC法同时检测复方氟尿嘧啶霜中3种成分

Determination of Three Components in Compound Fluorouracil Creams by HPLC

目的:建立高效液相色谱法同时测定复方氟尿嘧啶霜中氟尿嘧啶、甲氨蝶呤和氯霉素3种组分含量。方法:色谱柱为Lichrosphere C_(18)(250 mm×4.6 mm,5μm),流动相为甲醇:缓冲液(含10 mmol·L^(-1)NaH_2PO_4,20 mmol·L^(-1)四丁基溴化铵,用1 mol·L^(-1)NaOH将pH调为7.7)(45:55),检测波长为290 nm;流速1.0 ml·min^(-1),柱温45℃。结果:氟尿嘧啶、甲氨蝶呤及氯霉素线性范围分别为365.8～853.4 g·ml^(-1)(r=0.999 8),1.91～4.44 g·ml^(-1)(r=0.999 5)和191.5～446.9 g·ml^(-1)(r=0.999 4)。3种成分回收率分别为97.9%～100.0%,RSD为0.66%～2.74%。结论:本方法简便、可靠,适合于复方氟尿嘧啶霜的质量控制。

Objective：To establish an HPLC method for the determination of fluorouracil,methotrexate and choramphenicol in compound flurouracil creams.Method：A Lichrospher C_（18） column（250 mm×4.6 mm,5μm） was used.The mobile phase was mthanol; buffer（including 10 mmol·L^（-1） Na_2HPO_4 and 20 rnmol ？ L^（-1） tetra-n-butylammonium bromide,adjusting pH to 7.7 with 1 mol ？ L^（-1） of NaOH）（45：55）.The detection wavelength was set at 290 nm.The flow rate was 1.0 ml ？ min＂ and the column temperature was 45℃.Result;The linear range was 365.8-853.4 g ？ ml^（-1）（r =0.999 8） for fluorouracil,1.91-4.44 g ？ ml＂1（r =0.999 5） for methotrexate and 191.5-446.9 g ？ ml^（-1）（r = 0.999 4） for cholramphenicol,respectively.The recoveries of the three components were 97.9%-100.0%with RSD of 0.66%-2.74%.Conclusion：The method is simple,reliable and suitable for the quality control of compound flurouracil creams.