高效液相色谱荧光法测定人血浆中盐酸阿呋唑嗪浓度

HPLC for plasma concentration of alfuzosin hydrochloride

对盐酸阿呋唑嗪血浆药物浓度的测定方法及药物动力学进行了研究。方法 :用高效液相色谱法测定 ,LUNAC18(2 )色谱柱 ,5 μm粒径 (2 5 0mm×4.6mm) ;测定采用内标峰面积比定量 ,λex=2 70nm ,λem=370nm。结果 :本方法最佳线性关系为r =0 .9996 ,线性范围 5 0～ 0 .78μg·L-1,最低检测浓度为 0 .7μg·L-1;平均方法回收率 98.90 % ;5 0 ,2 0 ,1.5 μg·L-1的日内精密度分别为 3.74% ,4.72 % ,5 .6 8% ,日间精密度分别为 6 .0 0 % ,9.43% ,10 .2 7%。药物动力学参数分别为 :T1/2a=(1.1± 0 .7)h ,T1/2 β=(5 .7± 1.4)h ,Cmax=(32 .4± 6 .0 ) μg·L-1,Tmax=(1.14± 31)h ,AUC0～t=(2 18.8± 2 6 .0 ) μg·h·L-1。结论 :本方法灵敏、准确 ,可对血浆中盐酸阿呋唑嗪进行测定。

OBJECTIVE:A sensitive and precise HPLC for determination of alfuzosin hydrochloride plasma concentration was studied.METHODS:We used LUNA C 18 column,acetonitrile/0.02 mol·L -1 potassium dihydrogen phosphate(pH= 2.5) as a mobile phase.RESULTS:Methodology evaluation showed that alfuzosin hydrochloride plasma concentration between 50～0.7813 μg·L -1 had a good linear coefficient relation (r= 0.999 6). The lowest detectable concentration was 0.7 μg·L -1.The average recovery of the method was 98.9%.The coefficien variation of within and between-day for the concentration of 50、20 and 1.5 μg·L -1 were 3.74%、 4.72%、 5.68% and 6.00%、 9.43%、 10.27% respectively.Pharmacokinetics for alfuzosin hydrochloride tablet were T 1/2α=( 1.1± 0.7) h,T 1/2β=(5.7±1.4) h,C max=(32.4±6.0) μg·L -1,T max=( 1.14± 0.31) h.The area under the curve of concentration versus time after 5 mg oral of alfuzosin hydrochloride tablet was AUC 0～t=( 218.8± 26.0) μg·h·L -1.CONCLUSIONS:This method provides an accurate way in testing plasma concentration of alfuzosin.