Bioequivalence study of huperzine A in healthy volunteers with HPLC/MS/MS

OBJECTIVE To study the pharmacokinetics and bioequivalence of huperzine A in healthy volunteers.METHODS Twenty volunteers took the huperzine A tablets by oral with 2-way crossover design. The concentration of huperzine A in plasma was determined by HPLC/MS/MS. The pharmacokinetics parameters were calculated by BAPP software.RESULTS The calibration curve was linear in the range from 0.10 μg·L-1 to 6.38 μg·L-1. The extract recovery was more than 73.1 %. The intra and inter RSD was less than 10.2 %. The main pharmacokinetics parameters T1/2, Cmax,Tmax and AUC0-48 of the test tablets were (13.6±1.3) h, (1.9±0.5) μg·L-1 , (0.6±0.3) h and (19.9±2.7) μg·L-1·h, respectively. The pharmacokinetics parameters T1/2, Cmax, Tmax and AUC0-48 of the reference tablets were (13.6±1.1) h, (2.0±0.4) μg·L-1 , (0.60±0.20) h and (20.6±2.2) μg·L-1·h, respectively. The relative bioavalability of the test tablets was (96.8±10.1) %.CONCLUSION The HPLC/MS/MS method for determination of huperzine A in plasma is proved to be sensitive, accurate and convenient. The reference and test tablets are bioequivalent.