Commentary Open Access

Method Validation in Analytical Chemistry: Principles, Approaches, and Applications

Abstract

Method validation is a critical component of analytical chemistry that ensures the reliability, accuracy, precision, and reproducibility of experimental results. It establishes the fitness of an analytical method for its intended purpose and is essential in pharmaceuticals, clinical research, environmental analysis, food safety, and quality control laboratories. Regulatory agencies such as the International Council for Harmonisation (ICH), U.S. Food and Drug Administration (FDA), and European Medicines Agency (EMA) provide guidelines for method validation to ensure compliance and standardization. Key validation parameters include accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, and robustness. This article reviews the principles, methodology, applications, challenges, and emerging trends in method validation, highlighting its significance in ensuring analytical reliability and regulatory compliance.

Priya R. Sharma

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