Determination of Acrivastine in Human Plasma by HPLC and Its Pharmacokinetic Study / 中国药房

ABSTRACT

OBJECTIVE:To establish an HPLC method for the determination of acrivastine in human plasma and study its pharmacokinetics in healthy male volunteers. METHODS:The plasma sample was extracted with acetonitriles and concentrated and quantified with external reference method on a Symmetry ShieldTMPR18 column. The mobile phase was a mixture of acetonitrile-0.2% triethylamine (adjusted pH to 6.8?0.2 by dilute phosphoric acid solution,25∶75) at a flow rate of 1.0 mL?min-1. The column temperature was 35 ℃. The detection wavelength was set at 250 nm. RESULTS:The linear range of acrivastine was 4.687 5～600 ng?mL-1(r=0.999 4). The methodological recovery was 96.14%～98.89%; the intra-day RSD was 1.60%～3.00% and inter-day RSD was 2.03%～6.98%. The concentration-time pharmacokinetic parameters after oral administration of acrivastine capsules were in line with the one-compartment mode. CONCLUSION:The method is simple,sensitive,accurate with high recovery,and it is applicable for the concentration determination and clinical pharmacokinetic study of acrivastine.