Chromatography and Analytical Techniques

Chromatographic Method Validation

Chromatographic method validation ensures analytical methods are scientifically sound, reproducible, and suitable for their intended purpose. This critical step in quality assurance aligns with international guidelines such as those from the ICH, FDA, and EMA. Validation parameters include accuracy, precision, linearity, range, detection and quantitation limits, robustness, and specificity. As regulations tighten and analytical demands increase, method validation has become more complex and rigorous. Innovations in software tools, system suitability testing, and real-time validation protocols have streamlined the process and reduced human error. In pharmaceutical industries, validated chromatographic methods are essential for drug development, release testing, and stability studies. Environmental, food, and clinical laboratories also rely on method validation to ensure data integrity and regulatory compliance. With the expansion of hyphenated and automated technologies, validation protocols must now accommodate multi-analyte, multi-matrix environments. This session emphasizes the role of validated chromatography methods in delivering reliable, defensible results and showcases the latest practices and technologies that enhance validation efficiency across analytical workflows.