关键词: 阿魏酸哌嗪分散片, 阿魏酸哌嗪分散片, 阿魏酸哌嗪分散片, 药动学, 药动学, 药动学, 高效液相色谱, 高效液相色谱, 高效液相色谱

Abstract: Aim To establish a sensitive HPLC method for determination of piperazine ferulate and to study its pharmacokinetics in healthy volunteers. Methods Piperazine ferulate was separated on a Shimadzu C₁₈ column with acetic acid (0.1%)-methanol (60:40, V/V) as mobile phase after liquid-liquid extraction, and detection was performed at 310 nm. Piperazine ferulate pharmacokinetic parameters after a single oral dose of 200 mg of piperazine ferulate dispersible tablets in 20 healthy male volunteers were calculated and evaluated using DAS 2.0. Results The linear range of the calibration curve for piperazine ferulate was 5 - 3 000 ng·mL^-1, and the absolute recovery was about 70%. Intra-day RSD and inter-day RSD were less than 8.9% and 10.1%, respectively. The pharmacokinetic parameters, as Cmax, Tmax , t_1/2, AUC_{0 -4}, and AUC_0-∞, after a single oral dose of piperazine ferulate dispersible tablets were 1144.487 ± 599.839 ng·mL^-1, 0.373 ± 0.08 h, 0.805 ± 0.298 h, 604.01 ± 232.874 ng·mL^-1·h, and 611.778 ± 234.147 ng·mL^-1 ·h, respectively. Conclusion The HPLC method for determining piperazine ferulate concentration in plasma is rapid, sensitive and suitable for pharmacokinetic studies and routine determination of large samples.

Key words: piperazine ferulate dispersible tablet, piperazine ferulate dispersible tablet, pharmacokinetics, pharmacokinetics, HPLC, HPLC