Exploring the Evolution of Analytical Method Validation: Current Perspectives

Abstract

In this review, we delve into the critical process of analytical method development and validation within the realm of pharmaceutical drug development. The creation of sound analytical methods stands as a cornerstone from the early stages of drug discovery through to the eventual marketing approval. Our objective is to meticulously examine the methodology behind developing, optimizing, and validating analytical methods, particularly focusing on their application to drug products – from the formulation's developmental stage to the production of commercial batches. We begin by elucidating the significance of method development tailored to the specific components of finished drug products or in-process tests. Additionally, we delve into the intricacies of sample preparation techniques essential for accurate analysis. Central to our discussion are the practical approaches employed to ascertain critical parameters including selectivity, specificity, limit of detection, limit of quantitation, linearity, range accuracy, precision, recovery, solution stability, ruggedness, and robustness of liquid chromatographic methods. These parameters are indispensable for supporting routine, in-process, and stability analyses crucial for ensuring the safety, efficacy, and quality of pharmaceutical products. By dissecting the intricacies of method development and validation, this review aims to provide pharmaceutical researchers and practitioners with valuable insights and practical guidelines to navigate the complex landscape of analytical method validation in drug development.