Uncertainty evaluation for the determination of 10-hydroxycarbazepine in human serum by solid phase extraction-HPLC
10.13699/j.cnki.1001-6821.2015.11.018
- VernacularTitle:评定固相萃取－HPLC法测定人血清中10－羟基卡马西平浓度的不确定度
- Author:
Mao-Chang LIU
1
;
Yang WANG
;
Hua-Nian ZHANG
;
Hua XU
;
Yu-Jun CHEN
Author Information
1. 武汉市儿童医院药学部
- Keywords:
oxcarbazepine;
10-hydroxycarbazepine;
uncertainty;
solid phase extraction-HPLC;
serum drug concentration
- From:
The Chinese Journal of Clinical Pharmacology
2015;(11):960-963
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate uncertainty for the determination of oxcarbazepine active metabolite (10-hydroxycarbazepine) in human se-rum by solid phase extraction -HPLC.Methods The uncertainty caused in the whole process of determination was analyzed.Sources of uncertainty were established and simplified, then each component of un-certainty, combined uncertainty and expanded uncertainty were calculat-ed by using the method validation data in accordance with the evaluation procedure.Results The expanded uncertainty for low, medium and high concentrations (3.18, 12.73, 50.91 μg· mL-1 ) of 10-hydroxy-carbazepine was 0.24, 0.44 and 1.66 μg· mL-1 , respectively ( k =2, P=95%).Conclusion The uncertainty of this method was mainly caused by calibration curve fitting ( especially low level of sample ) , serum drug extraction, serum sample preparation, HPLC error and measuring repeatability.
