高效液相-串联质谱法测定人血浆中头孢拉定的质量浓度

目的:确立高效液相-串联质谱法(LC-MS/MS)测定人血浆中头孢拉定的质量浓度分析方法。方法:采用色谱柱为SymmetryShieldTMRp18(100mm×2.1mm,3.5μm);流动相为乙腈-水(8∶92);流速为0.3mL/min;内标为阿昔洛韦。结果:头孢拉定的血浆质量浓度在0.1～30.0μg/mL范围内线性良好,标准曲线方程为A=1.3ρ-0.00863(r=0.9970,n=8),定量下限为0.1μg/mL,日内RSD<3.90%,日间RSD<14.90%,方法回收率在107.60%～108.70%。结论:本法操作简单,结果准确,专属性强,灵敏度高,适用于头孢拉定药动学及生物等效性研究。

Determination of Cefradine in Human Plasma by LC-MS/MS Method

Objective：To establish a quantified analytical method for determination of Cefradine in human plasma by HPLC-MSMS. Methods： The HPLC-MSMS conditions adopted were as follows： Symmetry Shield^TM Rp18（100 mm× 2.1 mm, 3.5 μm）. The mobile phase consisted of acetonitrile-water （8∶92）. The flow rate was 0.3 mL/min. Acyclovir was used as internal standard. Results： In human plasma, the standard curve was linear from 0.1～30.0 μg/mL, A = 1.3 - 0.008 63（r = 0.997 0, n = 8）. The lower limit of quantification of cefradine was 0.1μg/mL. The RSD of within-day was less than 3.90%, the RSD of between-day was less than 14.90%, and the method recovery rate was 107.60%-108.70%. Conclusion： The assay was simple to operate, accurate, reliable and time-saving short analysis time. It is suitable for the clinical pharmacokinetics and bioequivalence studies.