Abstract��
OBJECTIVE To establish a HPLC method for bioavailability and pharmacokinetics of arbidol in human plasma.METHODS After adding SI-5,the internal standard,and 0.1 mol��L-1 NaOH solution,the plasma samples were extracted with cyclohexane and determined by HPLC.The HPLC column was C18 (4.6 mm��250 mm,5 ��m),the mobile phase was CH3 OH-1.32%TEA(80��20),the flow rate was 1.0 mL��min-1,the detection wavelength was 315 nm. A randomized crossover design was performed in 20 male volunteers after oral administration of arbidol test and reference preparations. RESULTS Calibration curves were linear over the range of 0.02��2.0 mg��L-1,the limit of detection was 0.01 mg��L-1.The main pharmacokinetic parameters of ��max,tmax and t1/2 were (0.879��0.175)mg��L-1,(0.7��0.3)h and (20.06��4.32)h for the test granules,and(0.741��0.167)mg��L-1,(1.2��0.4)h and (21.24��4.42)h for the reference tablets, respectively. The relative bioavailability of the test granules was (100.4��10.5)%.CONCLUSION The method is simple,accurate and sensitive. The statistic analysis shows that the two preparations were bioequivalent.