Links

Tools

Export citation

Search in Google Scholar

Chromatographic Methods Validation for Analysis of Small Molecules in Biological Matrices.

This paper was not found in any repository; the policy of its publisher is unknown or unclear.
This paper was not found in any repository; the policy of its publisher is unknown or unclear.

Full text: Unavailable

Question mark in circle
Preprint: policy unknown
Question mark in circle
Postprint: policy unknown
Question mark in circle
Published version: policy unknown

Abstract

CHROMATOGRAPHIC METHODS VALIDATION FOR ANALYSIS OF SMALL MOLECULES IN BIOLOGICAL MATRICES. Chromatographic methods are commonly used for analysis of small molecules in different biological matrices. An important step to be considered upon a bioanalytical method's development is the capacity to yield reliable and reproducible results. This review discusses validation procedures adopted by different governmental agencies, such as Food and Drug Administration (USA), European Union (EU) and Agencia Nacional de Vigilancia Sanitaria (BR) for quantification of small molecules by bioanalytical chromatographic methods. The main parameters addressed in this review are: selectivity, linearity, precision, accuracy, quantification and detection limits, recovery, dilution integrity, stability and robustness. Also, the acceptance criterions are clearly specified.