The Uncertainty Profile Used for Full Validation of the HPLC Method to Determine 22 Azo Amines in Fabrics.

This article focuses on the full validation of a high-performance liquid chromatography with diode array detection (HPLC–DAD) method for simultaneously quantifying 22 azo aromatic amines (AAz) in textile matrices, using an uncertainty profile approach based on b-content, c-confidence tolerance intervals. Azo dyes, widely used synthetic dyes in textiles, can degrade into carcinogenic amines, making accurate quantification essential for health and regulatory compliance. The study demonstrates that the uncertainty profile method effectively validates the HPLC–DAD assay by assessing accuracy, precision, and measurement uncertainty across concentration levels without additional experiments, achieving 67–90% compliance within acceptance limits set by ISO standards. This approach provides a comprehensive decision tool for laboratories to evaluate method reliability and manage analytical risks in routine testing of azo amines in textiles.