高效液相色谱法测定人体血浆中替加氟的方法研究

Study on the Determination of Tegafu in Human Plasma by HPLC Assay

目的建立一种高效液相色谱法测定人体血浆中替加氟浓度的方法。方法色谱柱为Zorbax-ODS C18（250 mm×4.6mm,5μm）,检测波长为273 nm,流动相为0.01 mol/L磷酸盐（用磷酸溶液调pH 5.2）-甲醇（85∶15）,流速1.0 mL/min,柱温为35℃。结果替加氟血药浓度在0.1-20μg/mL（r=0.999 7）内线性关系良好,最低检测浓度为0.1μg/mL,绝对回收率均在95%以上,相对回收率在94%-104%,日内、日间RSD分别为3.0%和4.1%。结论本方法简单、快速、准确,适用于临床药动学研究及血药浓度监测。

OBJECTIVE To establish an HPLC method for the determination of tegafur in human plasma. METHODS The determintion was performed by HPLC with the Zorbax-ODS C18 column（250 mm × 4.6 mm,5 μm） under 35℃ , the mobile phase was consisted of 0.01 mol/L phosphate buffer（ adjusted pH to 5.2 with orthophosphoric acid ） - methanol （ 85：15 ） with the flow rate at 1.0 mL/min, the UV detected wavelength was at 273 nm. RESULTS The linear ranges for determination of tegafur was 0.1 - 20 g/mL（ r =0. 999 7）, and the limit concentration of detection was 0.1 g/mL. Absolute recovery were more than 95%, relative recovery were 94% - 104% ; The RSDs of intra-day and inter-day were 3.0% and 4.1%. CONCLUSION This method was simple, quick, and accurate and can be used for studing the pharmacokinetics of tegafur and therapeutic drug monitoring.