abstract

Accurate particle size analysis is critical across various industries, including pharmaceuticals, materials science, and environmental engineering, as particle size distribution significantly influences product quality and performance. Analytical method development and validation ensure the reliability, accuracy, and reproducibility of particle size measurements. This systematic review examines the methodologies employed in the development and validation of analytical methods using particle size analyzers. It explores different types of particle size analyzers, key considerations in method development, validation parameters, and challenges faced during the process. By synthesizing findings from studies published up to 2020, this review provides comprehensive insights into best practices and emerging trends in particle size analysis. The results highlight the importance of instrument selection, sample preparation, parameter optimization, and rigorous validation protocols. This review serves as a guide for researchers and practitioners aiming to enhance their analytical methodologies in particle size analysis, ensuring high-quality and reproducible data.