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LC-MS法测定大鼠血浆中利可君浓度的不确定度评价

Uncertainty evaluation of the determination of leucogen concentrations in rat plasma by LC-MS

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【作者】 谢少斐张凤逸张含春李纬黄海燕

【Author】 XIE Shao-fei;ZHANG Feng-yi;ZHANG Han-chun;LI Wei;HUANG Hai-yan;Nanjing Changao Pharmaceutical Science and Technology Co., Ltd;

【机构】 南京长澳医药科技有限公司

【摘要】 目的评价LC-MS法测定大鼠血浆中利可君浓度的不确定度。方法对利可君血药浓度测定过程中各影响因素,包括精密度、称量、标准溶液配制、含药血浆配制、含药血浆提取、线性回归、仪器量化等进行分析评定和计算,根据各分量计算出合成不确定度并进行扩展。结果置信概率P为95%时,大鼠血浆中利可君低、中、高(100、1000、10 000 ng·m L-1)浓度的扩展不确定度分别为15.97、43.56、448.17ng·m L-1。结论线性回归过程和血浆提取过程对低浓度样品的不确定度贡献较大,而标准溶液配制过程对中、高浓度样品的不确定度贡献较大。

【Abstract】 Objective To evaluate the uncertainty in the determination of leucogen concentrations in rat plasma by LC-MS. Methods The influence factors in the whole process of determination were analyzed and calculated, including precision, weighing, standard solution preparation, drug-spiked plasma preparation, extraction process, calibration curve fitting, and equipment factor. The combined uncertainty was obtained by synthesizing the uncertainties of various component variables and then extended. Results The expanded uncertainty for the low, medium and high levels(100, 1000, 10 000 ng·m L- 1) of leucogen was 15.97, 43.56, and 448.17 ng·m L- 1(P = 95%). Conclusion The uncertainty for low level is mainly caused by calibration curve fitting and extraction. For the medium and high level, the uncertainty is mainly caused by standard solution preparation.

  • 【文献出处】 中南药学 ,Central South Pharmacy , 编辑部邮箱 ,2015年08期
  • 【分类号】R965;O657.63
  • 【被引频次】7
  • 【下载频次】73
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