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目的采用高效液相色谱-串联质谱法(HPLC-MS/MS)建立人血浆中卡马西平浓度测定方法,应用于药代动力学实验室生物样品检测室间质量评价。方法采用HPLC-MS/MS方法,以卡马西平-D8对照品为内标,Agilent Eclipse plus C18(4.6 mm×100 mm,3.5μm)为分析柱,流动相为含5 mmol/L甲酸铵的甲醇-水体系(90∶10,v∶v),流速为0.5 m L/min,采用多重反应监测(MRM)模式进行检测。结果卡马西平的线性范围为5~1 000 ng/m L(r2=0.998 9),定量下限为5 ng/m L,日内、日间精密度和准确度,绝对回收率和基质效应以及样品稳定性均符合生物样品测定需要,室间质评血样结果通过质量评价标准验证。结论本方法灵敏度高、特异性好,可用于人血浆中卡马西平的浓度测定以及药代动力学实验室生物样品检测室间质量评价。
OBJECTIVE To establish a method for the determination of carbamazepine in human plasma by HPLC-MS / MS, and to determine the concentration of carbamazepine in human plasma. Methods HPLC-MS / MS method with carbamazepine-D8 reference standard as internal standard, Agilent Eclipse plus C18 (4.6 mm × 100 mm, 3.5 μm) as the analytical column, the mobile phase containing 5 mmol / L ammonium formate Methanol-water system (90:10, v: v) at a flow rate of 0.5 m L / min was tested using multiple reaction monitoring (MRM) mode. Results The linear range of carbamazepine was 5-1 000 ng / m L (r2 = 0.998 9) and the lower limit of quantification was 5 ng / m L. The intra- and inter-day precision and accuracy, absolute recovery and matrix effects, Stability are in line with the determination of biological samples, room quality assessment of blood samples through quality evaluation standards. Conclusion The method is sensitive and specific and can be used for the determination of carbamazepine concentration in human plasma and pharmacokinetic laboratory bioassay for the detection of inter-laboratory quality.