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目的 本文建立了专属、灵敏的液质联用方法,用于人血浆中氯雷他定浓度的测定。方法 血样采用乙酸乙酯提取分离后,用质谱检测器的选择性离子检测模式(SIM)测定。结果 该方法的线性范围为0 .1～2 0mg·L-1(r =0 .9994 ) ,方法回收率在96 .8%～10 7.2 %之间,日内和日间RSD <13%。参比制剂和受试制剂的主要药动学参数cmax分别为(4.6 0±2 .4 3)和(4.85±2 .30 )mg·L-1,AUC0→2 4为(19.5 6±10 .2 4 )和(19.2 8±9.4 3)mg·h·L-1,T1/ 2 为(3.5 7±1.5 )和(3.15±1.2 )h ;tmax为(1.2±0 .4 )和(1.3±0 .5 )h。统计学结果表明:2种制剂间的主要动力学参数无明显差异,为生物等效制剂,其相对生物利用度为(98.6±7.2 ) %。结论 该法专属、灵敏,适用于氯雷他定药动学研究。经统计学分析,2种制剂具有生物等效性
Objective This article established an exclusive and sensitive LC / MS method for the determination of loratadine concentration in human plasma. Methods The blood samples were extracted with ethyl acetate and determined by selective ion detection mode (SIM). Results The linear range of this method was 0.1-2.0 mg · L-1 (r = 0.9994). The recoveries of the method ranged from 96.8% to 10 7.2%, and the intra-day and inter-day RSDs were less than 13%. The main pharmacokinetic parameters (cmax) were (4.6 ± 2.43) and (4.85 ± 2.30) mg · L-1, respectively. The AUC0 → 24 was (19.5 ± 6) (19.28 ± 9.43) mg · h · L-1, T1 / 2 was (3.57 ± 1.5) and (3.15 ± 1.2) h, tmax was (1.2 ± 0.4) and 0 .5) h. The statistical results showed that there was no significant difference in the main kinetic parameters between the two preparations, and the relative bioavailability was (98.6 ± 7.2)% for the bioequivalent formulation. Conclusion The method is exclusive, sensitive and suitable for loratadine pharmacokinetic studies. By statistical analysis, the two formulations have bioequivalence