A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Abstract

ABSTRACTIn this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should beapplied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and theirmetabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokineticstudies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigatedto decide the extent to which environment, matrix, or procedural variables can interfere the estimation of analyte in the matrix from the time of setup to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double massspectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographicmethods are HPLC and gas chromatography have been mainly used for the bioanlysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy,precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposedto add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug,concentration and its metabolite.Keywords: Method development, Clinical and nonclinical study, Analyte, Validation of bioanlysis techniques, Validation parameter.