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采用反相高效液相色谱法,以安定为内标,紫外236nm为检测波长,甲醇-水(70:30)为流动相,建立了测定血清中硝苯地平浓度的高效液相色谱法,药物浓度在15-480ng/ml范围内线性关系良好,Y=6.747×10~(-3)-1.891×10~(-3)X,γ=0.9998。平均回收率为100.1±0.56％,日内,日间精密度分别为4.93％、6.38％。用所建立方法测定了6名志愿者单剂量口服硝苯地平缓释片的相对生物利用度为105.4％。
High performance liquid chromatography (RP-HPLC) was developed for the determination of nifedipine in serum using reversed-phase high performance liquid chromatography with stability as an internal standard, ultraviolet detection wavelength of 236 nm and methanol-water (70:30) The linearity was good in the range of 15-480ng / ml, Y = 6.747 × 10 -3 -1.891 × 10 -3 X and γ = 0.9998. The average recovery was 100.1 ± 0.56%. The intra-day and inter-day precision were 4.93% and 6.38% respectively. The relative bioavailability of a single oral dose of nifedipine sustained-release tablets to 6 volunteers was determined using the established method as 105.4%.