高效液相-串联质谱方法测定法罗培南的血浆药物浓度

Determination of the Faropenem Concentration in Human Plasma By LC-MS/MS

目的采用高效液相-串联质谱方法测定血浆中法罗培南的药物浓度。方法色谱柱为ZORBAX Eclipse Plus(100mm×2.1mm,3.5μm),流动相:乙腈与5mmol/L醋酸铵缓冲液(含0.1%甲酸)体积比为35:65,流速为0.3ml/min,文拉法新为内标。结果法罗培南的血浆浓度在0.1～20μg/ml范围内线性良好,标准曲线方程为Y=0.2700c+0.00242(r=0.9955,n=8),定量下限为0.1μg/ml,日内精密度<5.4%,日间精密度<7.9%,回收率为99.0%～113%。结论该方法处理操作简单,结果准确,专属性强,灵敏度高,适用于法罗培南人体药动学研究及生物等效性研究。

Objective To establish a quantified analytical method for determination of faropenem in human plasma by LC-MS/MS.Method The LC-MS/MS conditions adopted were：ZORBAX Eclipse Plus（100 mm×2.1 mm,3.5 μm）.The mobile phase consisted of acetonitrile-5m mol/L ammonium acetate （35：65）.The flow rate was 0.3 ml/min.Wenlafaxine was used as internal standard.Results In human plasma,the standard curve was linear from 0.1～20 μg/ml,Y=0.270 0 c ＋ 0.002 42（r=0.995 5,n=8）.The lower limit of quantification of faropenem was 0.1μg/ml.The RSD of within-day was less than 5.4%,the RSD of between-day was less than 7.9%,and the method recovery rate was 99.0%～113%.Conclusion The assay is simple to operate,accurate,reliable and short analysis time,and makes it suitable for the clinical pharmacokinetics and bioequivalence studies.