HPLC法测定人血浆中氯雷他定的浓度

目的:建立以高效液相色谱法测定人血浆中氯雷他定浓度的方法。方法:色谱柱为KromasilC18柱,流动相为乙腈-标水为-0地.5西mo泮l·。L-结1磷果酸:氯氢雷二他钾定-磷血酸药(浓52度:4在3:05.5:～0.11)0,0流μg速·L为-11范.0围m内L·线mi性n-关1,系紫良外好检(测r波=长0.9为99237)5,n最m,低进检样测量浓为度2为0μ0L.5,柱μg·温L为-1室;方温法,内回收率为99.71%～102.41%;提取回收率为80.72%～83.78%;日内、日间RSD均<11%。结论:本方法适用于氯雷他定制剂的药动学及生物利用度研究。

Content Determination of Loratadine in Human Plasma by HPLC

OBJECTIVE：To develop an HPLC method for the content determination of loratadine in human plasam.METHODS：The separation was performed on Kromasil C18（200 mm×4.6 mm,5 μm） with mobile phase consisted of acetonitrile-water-0.5 mol·L^-1 potassium phosphate-phosphoric acid（52：43：5：0.1） at flow rate of 1.0 mL·min-1.The detection wavelength was set at 275 nm and injection volume was 20 μL.The column temperature was set at room temperature with diazepam as internal standard.RESULTS：The good linearity was obtained within 0.5～100 μg·L^-1（r=0.999 3）.The detection limit was 0.5 μg·L^-1 and the recovery ranged during 99.71%～102.41%.The absolute recovery was within 80.72%～83.78%.The RSD of intra-day and inter-day were less than 11%.CONCLUSION：Established method could be used for the pharmacokinetics and bioavailability study of loratadine.