A HOLISTIC APPROACH TO HPLC TECHNIQUEFOR ADDRESSING PROCESS IMPURITIES: REVIEW ONMETHOD DEVELOPMENT, OPTIMIZATION, AND VALIDATION

High-Performance Liquid Chromatography (HPLC) has become an indispensable analytical tool in pharmaceutical, environmental, and food sciences due to its precision, sensitivity, and versatility. A holistic approach to HPLC method development, optimization, and validation ensures reliable and reproducible results while meeting regulatory requirements. This review outlines the critical steps in HPLC method development, emphasizing the importance of understanding analyte properties, selecting appropriate chromatographic conditions, and fine-tuning parameters for optimal performance. Key aspects of method optimization, such as mobile phase composition, column selection, flow rate, and pH, are discussed to enhance resolution and reduce analysis time. Additionally, the article delves into the rigorous validation process, which includes assessing accuracy, precision, specificity, linearity, and robustness in compliance with International Council for Harmonisation (ICH) guidelines. By integrating systematic method development, experimental optimization, and thorough validation, this holistic framework ensures efficient and high-quality analytical methods, driving advancements in research and quality assurance across various industries.