Analytical Method Validation (AMV) is an essential process in pharmaceutical analysis that ensures analytical procedures are suitable, reliable, reproducible, and accurate for their intended use. Validation provides scientific evidence that the analytical method consistently produces acceptable results and complies with regulatory requirements. The International Council for Harmonisation (ICH) established globally accepted guidelines for analytical validation, particularly ICH Q2(R1) and the recently updated ICH Q2(R2), to harmonize pharmaceutical quality standards among different regulatory authorities. The present review focuses on a comparative study of analytical method validation parameters including specificity, accuracy, precision, linearity, range, robustness, ruggedness, limit of detection (LOD), and limit of quantitation (LOQ). The review also discusses lifecycle management, Quality by Design (QbD), risk-based analytical approaches, and modern trends incorporated in ICH Q2(R2). In addition, applications of validated analytical methods in pharmaceutical quality control, dissolution testing, impurity profiling, bioanalysis, and stability studies are highlighted. The review concludes that implementation of updated ICH validation principles enhances scientific understanding, method reliability, regulatory compliance, and patient safety.
Vishwakarma et al. (Mon,) studied this question.