AN ANALYTICAL REVIEW OF BIOANALYTICAL METHODDEVELOPMENT AND VALIDATION

Abstract

This research underscores the necessity of developing and validating bioanalytical processes for the precise assessment of medicines, metabolites, and biomarkers in biological matrices. Current procedures for sample preparation, chromatographic separation, and detection are examined, emphasizing LC-MS/MS. Selectivity, sensitivity, accuracy, precision, linearity, robustness, and stability are essential criteria for acceptable bioanalytical methods. Recent research examines common challenges, novel approaches, and best practices to improve the accuracy and reproducibility of bioanalytical assays. The project seeks to develop and evaluate procedures to guarantee bioanalytical precision in clinical trials, pharmacological investigations, and bioequivalence assessments.