Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect

Journal of Chromatography A

Volumn 1353, Issue , 2014, Pages 10-27

  González, Oskar ^a,b   Blanco, María Encarnación ^a   Iriarte, Gorka ^c   Bartolomé, Luis ^a   Maguregui, Miren Itxaso ^a   Alonso, Rosa M ^a  

^a UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

^b LEIDEN UNIVERSITY   (Netherlands)

^c Laboratory of Public Health of Alava Public Health and Addictions Directorate Basque Government   (Spain)

Author keywords

Bioanalysis; Limit of quantification; Matrix effect; Method validation; Robustness

Indexed keywords

CHROMATOGRAPHIC ANALYSIS; ROBUSTNESS (CONTROL SYSTEMS);

BIOANALYSIS; BIOANALYTICAL METHODS; CHROMATOGRAPHIC METHODS; CURRENT REGULATIONS; LIMIT OF QUANTIFICATIONS; MATRIX EFFECTS; METHOD VALIDATIONS; VALIDATION PARAMETERS;

ISOMERS;

ANALYTICAL PARAMETERS; CALIBRATION; CHROMATOGRAPHY; DILUTION; LIMIT OF QUANTITATION; LINEAR SYSTEM; MATRIX EFFECT; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; METHOD SELECTIVITY; MOLECULAR STABILITY; PHYSICAL PARAMETERS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; ROBUSTNESS; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY; INDICATOR DILUTION CURVE; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PROCEDURES; REPRODUCIBILITY;

CHROMATOGRAPHY, LIQUID; INDICATOR DILUTION TECHNIQUES; MASS SPECTROMETRY; REPRODUCIBILITY OF RESULTS; VALIDATION STUDIES AS TOPIC;

EID: 84903130675     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2014.03.077     Document Type: Review

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