RP-HPLC法测定人血浆中莫西沙星的浓度

目的:建立测定人血浆中莫西沙星浓度的方法。方法 :血浆样品采用萃取法处理后进行反相高效液相色谱(RP-HPLC)法分析,色谱柱为Agilent Eclipse XDB-C18,流动相为乙腈-水(含0.05%三氟醋酸,22∶78),流速为1.0ml/min,紫外检测波长为296nm(0².5min)、256nm(2.52.5min)、256nm(2.5⁴.5min)、296nm(4.54.5min)、296nm(4.5⁸.0min),柱温为25℃,进样量为20μl。结果:莫西沙星与内标的保留时间分别为6.2min和3.4min。莫西沙星血药浓度在0.058.0min),柱温为25℃,进样量为20μl。结果:莫西沙星与内标的保留时间分别为6.2min和3.4min。莫西沙星血药浓度在0.05¹0μg/ml范围内线性关系良好(r=0.999 6),定量下限为0.05μg/ml,日内、日间RSD分别低于3.96%、4.72%,低、中、高3个质量浓度及内标的提取回收率分别为72.13%、84.12%、85.85%和97.31%。结论:该检测方法简便、准确、专属性强,适用于临床莫西沙星的血药浓度检测及Ⅰ期临床试验。

Determination of Moxifloxacin Concentration in Human Plasma by RP-HPLC

OBJECTIVE： To establish a method for the determination of moxifloxacin concentration in human plasma. METHODS： After extracted, plasma sample was analyzed by RP-HPLC. The determination was performed on Agilent Eclipse XDB-C18 column with mobile phase consisted of acetonitrile-water （0.05% TFA, 22：78） at the flow rate of 1.0 ml/min. UV detection wavelengths were set at 296 nm （0-2.5 min）, 256 mn （2.5-4.5 min） and 296 nm （4.5-8.0 min）, respectively. The column temperature was 25 ℃ and injection volume was 20 μl. RESULTS： The retention time of moxifloxacin and internal standard were 6.2 min and 3.4 min, respectively. The linear range of moxifloxacin were 0.05-10 μg/ml （r=0.999 6）. The lower limit of quantitation （LLOQ） was 0.05 ~tg/ml. Intra-day and inter-day RSD were below 3.96% and 4.72%. The extraction recovery of low, medium, high concentration and internal standard were 72.13%, 84.12%, 85.85% and 97.31%. CONCLUSIONS： The method is simple, accurate and specific, and suitable for the determination of moxiftoxacin plasma concentration and I phase clinical test.