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目的:建立人血浆中硝苯地平代谢产物氧化硝苯地平血药浓度的高效液相色谱测定法。方法:以地西泮为内标,采用色谱柱为PhenomenexΜP-ODS C_(18)柱(250 mm×4.6 mm,5μm),柱温为30℃,流动相为甲醇-水(65∶35),流速为1.0 mL/min,进样量为20μL,紫外检测波长为245 nm;测定人血浆中硝苯地平代谢产物氧化硝苯地平血药浓度。结果:硝苯地平及氧化硝苯地浓度在2.0~200μg/mL范围内与其峰面积响应值(A)呈良好线性关系,分别得回归方程A_(硝苯地平)=267.34ρ+941.4(r~2=0.999 4),A_(氧化硝苯地)=5614.1ρ-314.1(r~2=0.999 6),该方法测得硝苯地平及氧化硝苯地平的最低定量下限为2.0μg/mL。结论:本法快速、准确,重现性好,符合方法学考察的要求,适用于人血浆中硝苯地平代谢产物氧化硝苯地平的血药浓度测定。
Objective: To establish a HPLC method for the determination of nifedipine in plasma of human plasma nifedipine metabolites. Methods: The internal standard of diazepam was PhenomenexMP-ODS C_ (18) column (250 mm × 4.6 mm, 5 μm) with the column temperature of 30 ℃ and the mobile phase of methanol-water (65:35) The flow rate was 1.0 mL / min, the injection volume was 20 μL and the UV detection wavelength was 245 nm. The plasma concentration of nifedipine metabolites in human plasma was determined. Results: The nifedipine and nifedipine showed a good linear relationship with the peak area response (A) in the range of 2.0 ~ 200 μg / mL. The regression equation A_ (nifedipine) = 267.34ρ + 941.4 (r ~ 2 = 0.999 4), A_ (nifedipine) = 5614.1ρ-314.1 (r ~ 2 = 0.999 6). The lowest limit of quantitation of nifedipine and nifedipine was 2.0μg / mL. Conclusion: The method is rapid, accurate and reproducible. It meets the requirements of methodological investigation and is suitable for the determination of plasma nifedipine metabolites in human plasma.