A REVIEW ON BIOANALYTICAL METHOD VALIDATION

Abstract

Bioanalytical method validation is a controlled procedure that comprises all the vital steps to establish that a certain method is capable of producing accurate, dependable and reproducible results that are appropriate for a specific analytical application. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use. Bioanalytical method validation is necessary in an analytical laboratory to show its qualification and competency. This article highlights how highly reproducible validated bioanalytical methods for the quantitative determination of drugs and/or metabolites in biological matrices can be achieved by advancing analytical sensitivity.