反相高效液相色谱法测定盐酸左旋氧氟沙星的血药浓度

Determination of Levofloxacin Hydrochloride in Human Plasma by RP-HPLC

目的 :测定国产左旋氧氟沙星胶囊剂和进口片剂口服后的血药浓度和人体药动学研究。方法 :色谱柱采用PhenomenexLunaC18(2 ) ,流动相为乙醇 - 0 2mol·L-1醋酸铵 (pH 2 4) (16∶84) ,荧光检测 (λex=2 95nm ,λem=480nm ) ,血浆样品经沉淀蛋白后直接进样。结果 :血药浓度线性范围 0 0 6～ 3 0 8μg·mL-1(r =0 9994) ,净化回收率 81 5 8%～ 87 76 % ,平均方法回收率 96 94%～ 10 2 2 % ,日内、日间相对标准偏差分别为 2 2 %～ 4 6 %和 1 2 %～ 3 7%。结论 :用乙醇作反相高效液相色谱流动相溶剂较甲醇有利于环境保护 ,建立的方法简便、灵敏、准确。

Objective:To determine the concentration of levofloxacin(LVFX) in human plasma after a single dose of domestic LVFX capsule or imported LVFX tablet by RP-HPLC and to study the pharmacokinetics of LVFX.Methods:The prepared sample was injected onto the column of Phenomenex Luna C 18 (2)(150 mm×4 6 mm,5 μm),with ethanol-0 2 mol·L -1 ammonium acetate buffer(pH 2 4)(16∶84) as mobile phase,LVFX was detected with fluorescene(λ ex =295 nm,λ em =480 nm).Results:The calibration curve was linear in the range of 0 06 to 3 08 mg·L -1 ( r =0 999 4),the clean-up recovery of LVFX was 81 58%～87 76%,the analytical recovery was 96 94%～102 2%,the RSD s of within-day and day-to-day were 2 2%～4 6% and 1 2%～3 7% respectively.Conclusions:The method was simple,sensitive and good enough to be used in pharmacokinetic study of LVFX.Ethanol used as RP-HPLC mobile phase solvent is of significance for the environmental protection.