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目的 建立高效液相色谱法荧光检测血浆中氯雷他定 (loratadine)含量的方法 ,以评价氯雷他定的相对生物利用度。方法 色谱柱为AlltechC18,4 6mm× 150mm ;流动相为乙腈 水 冰醋酸 三乙胺 (90∶10 0∶6∶0 15) ;流速为 1mL·min- 1;荧光检测器测定波长 ,Ex=2 74nm ,Em=450nm。结果 HPLC测定线性范围为 0 2～ 3 0 μg·L- 1,最低定量限 0 2 μg·L- 1,方法回收率为 96%～ 98%。人体生物利用度结果表明 ,实验片、胶囊与对照片间的AUC ,Tmax,Cmax和T1 2 β均无显著性差异 (P >0 0 5) ,两者的相对生物利用度分别为 10 7%± 17%和 10 0 %± 14 %。AUC和Cmax经可信区间法检验生物等效。结论 3种制剂生物等效
Objective To establish a method for the determination of loratadine in plasma by high performance liquid chromatography (HPLC), and to evaluate the relative bioavailability of loratadine. Methods The column was Alltech C18, 4.6 mm × 150 mm. The mobile phase was acetonitrile-water glacial acetic acid triethylamine (90:10 0:6:015), the flow rate was 1 mL · min-1. The fluorescence detector measured the wavelength and Ex = 2 74 nm, Em = 450 nm. Results The linear range of HPLC was 0.2-2.0 μg · L-1 and the lowest limit of quantification was 0.2 μg · L-1. The recovery was 96% -98%. The results of human bioavailability showed that there was no significant difference in AUC, Tmax, Cmax and T1 2 β between experimental tablets, capsules and control tablets (P> 0.05), and the relative bioavailability of the two drugs were 107% ± 17% and 10 0% ± 14%. AUC and Cmax were bioequivalent by confidence interval test. Conclusions The three formulations are bioequivalent