Bioanalytical Method Development and Validati...

ABSTRACT

Bioanalytical methods are specifically for the interpretation of bioequivalence, pharmacokinetics, toxicokinetics and estimation of drug, enzymes and metabolite in a biological matrix such as plasma, serum & urine. Bioanalytical methods should be applied in clinical as well as in vitro study. The main impact of bioanalytical method is to obtain quantitative measures drugs and metabolite n biological matrix. A bioanalytical method is a combination of different procedures which are collection sample, processing, storage and analysis of biological sample. Techniques used to perform bioanalysis vary according to the nature of analyte. Hence, to find out the best suitable bioanalytical method for the purpose of quantification of analyte, the method validation is important. Various bioanalytical techniques are available for the bioanalytical studies such as chromatographic techniques, spectroscopic techniques, hyphenated techniques and ligand binding assay. During drug research, the developed bioanalytical methods are utilised to measure and define the required dosage, acceptable impurity, stability and bioavailability of the drug. Now a day HPLC-UV, RP-HPLC, LC-MS, LC-MS/MS this are widely used hyphenated analytical techniques which showed most linearity, stability, reproducibility, precision, selectivity, accuracy, sensitivity while performing validation. In this review article, we have introduced some steps regarding bioanalytical method development and validation parameters used in quality assurance for determination of concentration of drugs and its metabolites.

Keywords: Bioanalytical method, Bioequivalence, Biological matrix, Method validation, LC-MS/MS, RP-HPLC, HPLC-UV