Study on Bioequivalence of Telmisartan Dispersible Tablets

Objective To develop a HPLC method with fluorescent detection to determine telmisartan in human plasma and investigate the pharmacokinetics profiles and bioequivalence of telmisartan in healthy chinese volunteers.Methods In a randomized two period crossover study,18 healthy male volunteers received single dose of 80 mg telmisartan.The serum concentration of telmisartan was determined by HPLC method.The pharmacokinetic parameters of the two preparations and the relative bioavailability after oral administration were calculated with statistic analysis.The column was Diamonsil C18(5 μm,4.6 mm×150 mm).The mobile phase consisted of acetonitrile-potassium dihydrogen phosphate buffer solution(77∶23,pH adjusted to 3.10 with H3PO4) at a flow rate of 1 mL/min.The fluorescence detector was operated at λEx=305 nm and λEm=365 nm.Results The calibration curve of telmisartan was linear in the range of 2～512 μg/L(r=0.999 9).The absolute recovery was 84.33%,81.56%,and 87.22%(n=5),AUC0~96 of the test and reference preparations was(3 439.58±1 393.38)and(3 419.85±993.25)μg·h/L respectively.Conclusion Statistical analysis showed that the two preparations were bioequivalent.