Uncertainty Evaluation in Carbamazepine Determination in Human Plasma by HPLC-MS/MS / 中国药师

ABSTRACT

Objective:To evaluate the uncertainty in carbamazepine ( CBZ) determination in human plasma by HPLC-MS/MS. Methods:The whole process of CBZ determination was analyzed and the uncertainty sources were established, and then the uncertainty was evaluated and combined, and the expanded uncertainty was also calculated. Results: The expanded uncertainty of CBZ with low (7.46 ng·ml-1) and high (745 ng·ml-1) levels was 0.410 ng·ml-1 and 33.400 ng·ml-1, respectively (P=95%, k=2). Conclusion:The uncertainty in CBZ determination in human plasma by HPLC-MS/MS is mainly caused by recovery, sample prepara-tion and matrix effect for low concentration, and by sample preparation and repeatability for high concentration.