摘要
目的:对人血浆利培酮浓度液质联用法(HPLC-MS/MS)测定的不确定度进行评定。方法:对HPLC-MS/MS法测定血浆中利培酮浓度的全过程进行分析,对于分析过程中称量、溶液配制、液液萃取、仪器以及标准曲线拟和等影响因素引起的不确定度进行了逐层分析,用A类评定程序评价了分析过程中随机效应引起的不确定度,用B类评定程序评价了分析过程的其他因素引起的不确定度,最后根据各分量计算出合成不确定度并进行了扩展。结果:置信概率P为95%时,血浆低(0.65ng·mL-1)、中(10.86ng·mL-1)、高(21.72ng·mL-1)浓度利培酮的扩展不确定度分别为0.24,0.35,0.70ng·mL-1。结论:该方法适用于HPLC-MS/MS法测定血浆中利培酮浓度的不确定度评定,为复杂生物基质分析过程的不确定度评定提供了重要参考。
Objective:To evaluate the uncertainty of risperidone in human plasma by HPLC-MS/MS.Method:The uncertainty caused by various factors in the whole process of determination,including balancing,solution preparation,extraction process,calibration fitting and the equipment,was estimated.The uncertainty caused by random effects was evaluated with type A and others were by type B.The combined uncertainty was calculated with all the components.Results: The expanded uncertainty for low,medium and high level of risperidone was 0.24,0.35 and 0.70 ng·mL-1,respectively (P=95%).Conclusion:This method is applicable for the uncertainty evaluation of risperidone determination in human plasma.It provides an important reference for the uncertainty evaluation for the determination in complex bio-matrix.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第3期366-371,共6页
Chinese Journal of Pharmaceutical Analysis