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目的:建立测定人血浆中EXH-1626浓度的HPLC方法。方法:采用美国Waters Symmetry Shield~(TM) RP_(18)(250 mm×4.6 mm,5μm)色谱柱;流动相为磷酸二氢钾缓冲液-甲醇(30:70),流速1.0 ml·min~(-1);检测波长281 nm;柱温30℃;血样品经全血沉淀剂直接沉淀蛋白后进样。结果:EXH-1626血浆浓度与峰面积线性关系良好,回归方程为A=2.566 7×10~4C+1.768 6×10~3,r=0.999 5;线性范围0.05～10.00μg·ml~(-1),定量下限为0.05μg·ml~(-1),血浆内源性杂质不干扰待测物测定。结论:该法可用于EXH-1626血药浓度的含量测定,专属准确、快速。
Objective: To establish an HPLC method for the determination of the concentration of EXH-1626 in human plasma. METHODS: Waters Symmetry Shield RP18 (250 mm × 4.6 mm, 5 μm) column was used. The mobile phase was potassium dihydrogen phosphate buffer (30:70), the flow rate was 1.0 ml · min ~ (-1). The detection wavelength was set at 281 nm. The column temperature was 30 ℃. The blood sample was directly precipitated by whole blood precipitating agent before injection. RESULTS: The linear relationship between EXH-1626 plasma concentration and peak area was good. The regression equation was A = 2.566 7 × 10-4C + 1.768 6 × 10-3, r = 0.999 5. The linear range was 0.05-10.00μg · ml -1 ). The lower limit of quantification was 0.05μg · ml -1. Plasma endogenous impurities did not interfere with the determination of analytes. Conclusion: The method can be used to determine the concentration of EXH-1626 blood serum, accurate and fast.