A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION

In bioanalytical methods are widely used to quantitative drugs and their metabolites in plasma matrices and the methods should be applied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and their metabolites in biological media and plays an important role in estimation and interpretation bioequivalence, pharmacokinetic, toxicokinetic, studies. The major bioanalytical role is method development and sample analysis liquid-chromatography coupled with double mass spectroscopy can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographic methods are HPLC and gas chromatography have been mainly used for the bioanalysis of small/large molecules, with LC/MS. Linearity, accuracy, precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposed to 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 bioanalysis techniques, validation parameter.