人血浆中硝呋太尔的HPLC-UV测定

HPLC Determination of Nifuratel in Human Plasma with Ultraviolet Detection

目的:建立测定人血浆中硝呋太尔血药浓度的方法。方法:采用反相 HPLC 法,以呋喃妥因为内标,血浆样品经乙酸乙酯提取后,氮气吹干,流动相复溶后进样测定。色谱柱:C_(18)柱(250 mm×4.6 mm,5μm);流动相:甲醇-乙腈-四氢呋喃-水-磷酸-二乙胺(20:20:5:55:0.2:0.2),流速为1.0 mL·min^(-1);紫外检测波长:363 nm。结果:硝呋太尔的线性范围为1.0～80.0 ng·mL^(-1),定量限为1 ng·mL^(-1);日内、日间 RSD 均小于6.9%,相对回收率为97.1%～100.4%,提取回收率均大于83.6%。结论:该法准确、灵敏,可用于硝呋太尔的临床药代动力学研究。

Objective：To develop a method for determination of nifuratel in human plasma. Method：Plasma sampies were extracted with ethyl acetate containing furadantin as internal standard and chromatographic separation was accomplished on C18 column（250 mm × 4. 6 mm ,5 μm）using a mobile phase consisting of methanol - aeetonitrile - tetrahydrofuran - water - phosphoric acid - diethylamine （ 20 ： 20 ： 5 ： 55 ： 0. 2 ： 0. 2 ） with ultraviolet detection at 363 nm. The flow rate was 1.0 mL · min^-1. Result：The limit of quantification was 1.0 ng · mL^-1 ,the linear range was 1.0- 80. 0 ng · mL^-1. The within -day and between -day RSDs were less than 6.9% ,the relative recovery was between 97. 1% - 100. 4% and the extraction recovery was above 83.6%. Conclusion：The method was specific, sensitive and suitable for drug plasma level monitoring in clinical pharmacokinetic study.