Pharmacokinetics of levodropropizine dispersible tablets in healthy volunteers
AIM: To establish a simple HPLC assay for determining levodropropizine in human serum and to study the pharmaco-kinetics characteristics of levodropropizine dispersible tablets in healthy volunteers. METHODS: The analytical column was Dia-monsil C18 (250 mm × 4. 6 mm, 5 μm) , the mobile phase was acetonitrile-water- acetic acid- triethylamine ( 5:95:0. 5:0. 25) , the flow rate was 1 mL/min, and the injection volume was 20 μL, with fluorimetric detection (λex 240 nm, λem 350 nm). RESULTS: The linear range of levodropropizine in human plasma was 10 ~ 1000 μg/L (r =0.997) , the lowest detectable concentration was 3 μg/L, the average recovery was (92. 4 ± 3.7)% , and the RSDs of within-day and between-day were less than15% (n=5). The main pharmacokinetic parameters of levodropropizine dispersible tablets were: Tmax (0.95 ±0.24) h, Cmax (386 ±101) μg/L, AUC(0- 12 h) (833±246) μg·h/L, t1/2 (1.72 ±0.64) h. CONCLUSION: Accurate and sensitive, simple and rapid, HPLC assay can be used for blood concentration monitoring and pharmacokinetic study.
NETL
NSTL
万方数据
维普
