Determination of gliqudone in human plasma by HPLC-fluorescence and bioequivalence of 2 gliqudone tablets

Objective To determine gliqudone in the plasma and evaluate the bioequivalence of 2 gliqudone tablets(T and R)by HPLC-fluorescence method.Methods Gliqudone was separated on a C18 column with a mixture of methanol-phosphate buffer solution(60∶40,v/v,pH value was adjusted to 7.35 by NH3·H2O)as the mobile phase,and was detected at EX:315 nm,EM:410 nm.A single oral dose of 60 mg gliqudone was administered to 18 healthy volunteers in a randomized crossover study,and the pharmacokinetics and bioavailability were studied.Results Gliqudone was separated well with the endogenous substances.The calibration curve was linear at 30.5～1 950 μg·L-1 with r2=0.999 1,the absolute recovery was at 81.7% ～103.6%(n=15),and the method recovery was 89.3%～108.7%(n=15).Inter-day RSD1.3% and intraday RSD2.4%,with the AUC0~24 as the index,the relative bioavailability of tablet T was(101.5±13.3)% when compared with tablet R.Conclusion The established method is accurate and sensible for the determination of gliqudone in human plasma.Statistic analysis showed no significant difference between the two preparations,which are bioequivalent.