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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

刘茂昌 汪洋 张华年 徐华 陈渝军

中国临床药理学杂志Issue(11):960-963,4.
中国临床药理学杂志Issue(11):960-963,4.DOI:10.13699/j.cnki.1001-6821.2015.11.018

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

Uncertainty evaluation for the determination of 10-hydroxycarbazepine in human serum by solid phase extraction-HPLC

刘茂昌 1汪洋 1张华年 1徐华 1陈渝军1

作者信息

  • 1. 武汉市儿童医院药学部,武汉 430016
  • 折叠

摘要

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.

关键词

奥卡西平/10-羟基卡马西平/不确定度/固相萃取-高效液相色谱法/血药浓度

Key words

oxcarbazepine/10-hydroxycarbazepine/uncertainty/solid phase extraction-HPLC/serum drug concentration

分类

医药卫生

引用本文复制引用

刘茂昌,汪洋,张华年,徐华,陈渝军..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[J].中国临床药理学杂志,2015,(11):960-963,4.

基金项目

2014年度武汉市临床医学科研基金资助项目 ()

中国临床药理学杂志

OA北大核心CSCDCSTPCD

1001-6821

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