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目的:建立反相高效液相色谱法测定人血浆中兰索拉唑的浓度。方法:色谱柱为Agilent Eclipse XDB C_(18)(150 mm×4.6 mm,5μm),流动相为0.01 mol·L~(-1)磷酸二氢铵(内含1‰正辛胺)-乙腈(66:34),流速为1.0 ml·min~(-1),检测波长为285 nm,内标为奥美拉唑。结果:兰索拉唑的线性范围为0.01-2.00μg·ml~(-1),回归方程为Y=0.0019C+0.0022(r=0.999 4);批内RSD为2.95%~3.25%,批间RSD为1.09%-1.95%。结论:本方法操作简便,测定结果准确,检测限较低,重现性好,可用于兰索拉唑人体药物动力学研究。
Objective: To establish a method for the determination of lansoprazole in human plasma by reversed-phase high performance liquid chromatography. METHODS: The column was Agilent Eclipse XDB C 18 (150 mm × 4.6 mm, 5 μm) with a mobile phase of 0.01 mol·L -1 ammonium dihydrogen phosphate (containing 1 ‰ n-octylamine ) - acetonitrile (66:34) at a flow rate of 1.0 ml · min ~ (-1). The detection wavelength was 285 nm and the internal standard was omeprazole. Results: The linear range of lansoprazole was 0.01-2.00μg · ml -1, the regression equation was Y = 0.0019C + 0.0022 (r = 0.999 4). The intra-assay RSD was 2.95% ~ 3.25%, inter-batch RSD was 1.09% -1.95%. Conclusion: The method is simple, accurate, accurate and reproducible. It can be used in human pharmacokinetics study of Lansoprazole.