A COMPREHENSIVE REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR PHARMACEUTICALS

Bioanalysis is most widely used for drug discovery and development. Bioanalytical methods have been working for the quantitative estimation of drugs, or its metabolites and biomarkers in its biological samples. The steps involved in bioanalysis comprise of many steps that are from sample collection to sample analysis and then data reporting. The first step involves sample collection from clinical or preclinical studies. After that, the analysis of the sample is done in the laboratory. The second step involves the sample cleanup the cleanup process should be carried out carefully to eliminate the interferences present in the sample matrix. And it increases the performance of the analytical system. The last step involves sample analysis and detection of a separated compound and detection of techniques used are HPLC and Liquid chromatography coupled with double mass spectrometry (LCMS-MS) and are used in the bioanalysis of drugs in the body. Each one of these has its advantage and disadvantage. For bioanalysis of small or large molecules the chromatographic methods used are HPLC, and Gas Chromatography with LC/MS/MS. The review focuses on an overview of the bioanalytical method, development, validation, and the quality of sample preparations.