Determination of venlafaxine in human plasma and bioequivalence with HPLC-MS/MS

Objective To investigate the bioequivalence of venlafaxine hydrochloride capsules in Chinese healthy volunteers.Methods 50 mg test preparation and reference preparation were given to 24 male healthy volunteers in randomized two-way crossover design and blood samples in 36 h were collected.HPLC-MS/MS was used to determine plasma concentrations of venlafaxine.The pharmacokinetics and relative bioavailability were calculated by DAS to evaluate bioequivalence.Results The main pharmacokinetic parameters of the two preparation were as follows: Cmax were(59.32±17.21) and(60.58±17.42) μg·L-1,Tmax were(2.08±0.46) and(2.25±0.55) h,T1/2 were(6.69±1.67) and(6.35±1.69) h,AUC0-36 were(524.65±227.01) and(528.22±226.57) μg·L-1·h,AUC0-∞were(544.81±246.05) and(546.85±244.62) μg·L-1·h,respectively.The mean relative bioavailability of test preparation and reference preparation were(100.37±10.41)%.Conclusion The statistical analysis shows the two preparations are bioequivalent.