Quantitative determination of endogenous compounds in biological samples using chromatographic techniques

被引:207
作者
van de Merbel, Nico C. [1 ]
机构
[1] PRA Int, Early Dev Serv, Bioanalyt Lab, NL-9405 BJ Assen, Netherlands
关键词
Biological sample; Biomarker; Calibration; Chromatography; Endogenous compound; Method development; Quantitative determination; Surrogate analyte; Surrogate matrix; Validation;
D O I
10.1016/j.trac.2008.09.002
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Chromatographic methods are increasingly being used for the quantitative determination of endogenous compounds in biological samples. This article presents an overview of the specific issues, which have to be taken into account for the development, validation and application of these methods. The usual lack of analyte-free samples of the biological matrix implies that alternative strategies for calibration have to be followed. This article compares and discusses the advantages and disadvantages of two strategies - the use of the authentic analyte in a surrogate matrix and the use of a surrogate analyte in the authentic matrix. In addition, it highlights important aspects of the validation of chromatographic methods for endogenous analytes. (C) 2008 Elsevier Ltd. All rights reserved.
引用
收藏
页码:924 / 933
页数:10
相关论文
共 43 条
[1]  
BOOMSMA F, 1993, CLIN CHEM, V39, P2503
[2]   Validation of liquid chromatographic and gas chromatographic methods - Applications to pharmacokinetics [J].
Bressolle, F ;
BrometPetit, M ;
Audran, M .
JOURNAL OF CHROMATOGRAPHY B-BIOMEDICAL APPLICATIONS, 1996, 686 (01) :3-10
[3]   Validation issues arising from the new FDA guidance for industry on bioanalytical method validation [J].
Brodie, RR ;
Hill, HM .
CHROMATOGRAPHIA, 2002, 55 (Suppl 1) :S91-S94
[4]  
Burtis CA., 2006, TIETZ TXB CLIN CHEM, V4th
[5]   Testosterone measurement by isotope-dilution liquid chromatography-tandem mass spectrometry: Validation of a method for routine clinical practice [J].
Cawood, ML ;
Field, HP ;
Ford, CG ;
Gillingwater, S ;
Kicman, A ;
Cowan, D ;
Barth, JH .
CLINICAL CHEMISTRY, 2005, 51 (08) :1472-1479
[6]   APPLICATION ISSUES IN BIOANALYTICAL METHOD VALIDATION, SAMPLE ANALYSIS AND DATA REPORTING [J].
DADGAR, D ;
BURNETT, PE ;
CHOC, MG ;
GALLICANO, K ;
HOOPER, JW .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1995, 13 (02) :89-97
[7]   Issues in evaluation of bioanalytical method selectivity and drug stability [J].
Dadgar, D ;
Burnett, PE .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1995, 14 (1-2) :23-31
[8]   APPLICATIONS OF ISOTOPE-DILUTION MASS-SPECTROMETRY IN CLINICAL-CHEMISTRY, PHARMACOKINETICS, AND TOXICOLOGY [J].
DELEENHEER, AP ;
THIENPONT, LM .
MASS SPECTROMETRY REVIEWS, 1992, 11 (04) :249-307
[9]   AN ANALYSIS OF THE WASHINGTON CONFERENCE REPORT ON BIOANALYTICAL METHOD VALIDATION [J].
HARTMANN, C ;
MASSART, DL ;
MCDOWALL, RD .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1994, 12 (11) :1337-1343
[10]   Validation of bioanalytical chromatographic methods [J].
Hartmann, C ;
Smeyers-Verbeke, J ;
Massart, DL ;
McDowall, RD .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1998, 17 (02) :193-218