反相高效液相色谱法测定人血浆中拉呋替丁药物浓度

Determination of lafutidine in serum with reverse high performance liquid chromatography

目的：建立拉呋替丁血药浓度的反相高效液相色谱测定方法。方法：采用Symmetry·C18色谱柱（54μm,4.6Inm×150mm）；固定进样环20μL；流动相：甲醇：O.005moI/L磷酸氢二铵=50：50（V：V）；流速：l mL/min；紫外检测波长：218nm；柱温：25℃。结果：拉呋替丁在O.506～O.01265mg/L范围内有良好的线性关系，其506.00、50.60、12.65μg/L的三个浓度的回收率分别为（99.05±3.31）％、（101.21±3.30）％、（94.87±3.18）％；日内RSD分剐为3.44％、3.75％、4.67％。日间RSD分别为4.68％、6.98％、9.42％。结论：谊方法简单、快速、准确,灵敏度高,可用于拉呋替丁的血药浓度测定及药动学研究。

Objective：To establish the method for measuring lafutidine pharmacal concentration in blood with reverse high performance liquid chromatography （HPLC） .Methods：HPLC was equipped with Symmetry·Cl8 column （54 μm, 4.6 mmx 150mm）. The mobile phase was methanol-0.005 mol/L （NH4）2HPO4=50：50（V/V）, flow speed was 1.0 mL/min, column temperature was 25℃, ultraviolet wavelength was 218 nm.Results：Within the range of 0.506～0.01265 mg/L,Lafutidine showed a good linear relation in HPLC. The recoveries of three concentration 506.00, 50.60,12.65 μg/L were （99.05±3.31 ） %, （ 101.21±3.30） %, （94.87±3.18） %, respectively. The RSD of inter-day variation of lafutidine were 3.44% ,3.75%, 4.67% and the intra-day variation were 4.68%, 6.98%, 9.42%. Conclusions：This method is simple, quick, accurate and of high sensitivity. It can be used for assay of lafutidine pharmacal concentration in blood and for the research of the pharmacokinetics of lafutidine.