Uncertainty evaluation on determination of risperidone in human plasma by HPLC-MS/MS

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.