Bioanalytical liquid chromatographic method validation. A review of current practices and procedures
Bioanalytical liquid chromatographic method validation. A review of current practices and procedures
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DOI：
10.1081/jlc-100101455
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发表时间：
2000-01-01
影响因子：
1.3
通讯作者：
Beijnen, JH
中科院分区：
文献类型：
--
作者：
Rosing, H;Man, WY;Beijnen, JH
分析方法的验证被广泛认为是投入常规使用之前的关键。在监管机构发布的指南中，其行为和接受标准仍然存在个人解释的余地。本文的目的是回顾所使用的性能，并提供实用的方法来确定液相色谱方法的选择性、特异性、检测限、定量下限、线性、范围、准确度、精密度、回收率、稳定性、耐用性和鲁棒性，以支持药代动力学研究。对抗癌药物生物分析中使用的液相色谱程序的最新文献进行的调查表明，验证所采用的标准差异很大。
Validation of analytical methodologies is widely accepted as pivotal before they are put into routine use. Within the guidelines issued by Regulatory Authorities, there still exists scope for individual interpretation with respect to their conduct and acceptance criteria. The intention of this paper is to review the performances used and to provide practical approaches for determining selectivity, specificity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness of liquid chromatographic methods to support pharmacokinetic studies. A survey of recent literature on liquid chromatographic procedures used in the bioanalysis of anticancer drugs revealed that very variable standards were employed for validation.