����2D-HPLC��ϲ����������ⶨ��Ѫ��˫�ȷ�����Ũ�ȼ���Ӧ��

Determination of Diclofenac Sodium in Human Plasma Based on 2D-HPLC Coupled with Trapping Column and Its Application

??OBJECTIVE To establish a method for determination of diclofenac sodium in human plasma under high-fat meal condition using two-dimensional liquid chromatography (2D-HPLC) coupled with trapping column, and to evaluate the bioequivalence and the bioavailability of diclofenac sodium sustain-released tablets in healthy volunteers. METHODS Under fed state, eighteen healthy male volunteers were divided into two groups by an open, randomized two period crossover design with a single dose of diclofenac sodium sustain-released tablets. The plasma concentrations were determined by 2D-HPLC method, and calculated pharmacokinetic parameters and bioavailability. RESULTS The main pharmacokinetic parameters of test and reference preparations after a single dose were: AUC_0??16 was (2 591.6 ?? 705.8 ) and (2 588.8??772.0) ng??h??mL^-1;AUC_0????was (2 896.4??839.7) and (2 700.3??806.1) ng??h??mL^-1; t_max was (4.6??0.7) and (4.4??0.9)h; ??_max was(1 332.8??912.5) and (1 325.7??706.3) ng??mL^-1, respectively. The relative bioavailability of test preparation in single dose was (102.4??15.1)%. CONCLUSION The 2D-HPLC method coupled with trapping column is a simple, rapid and specific for determination of diclofenac sodium in human plasma. The RESULTS of statistical analysis indicate that the two preparations are bioequivalent in healthy volunteers with a single dose under high-fat fed condition.