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

Abstract

Background: Azo dyes are synthetic dyes that can degrade to carcinogenic amines, therefore determining their exact concentration is crucial.

Objective: The purpose of this study is to demonstrate that an HPLC method may be used to quantify 22 azo dye amines in a textile matrix.

Methods: The HPLC-DAD (Diode Array Detector) technique for measuring 22 amines in a textile matrix was tested using a new graphical statistical strategy based on the building of β-content, γ-confidence tolerance intervals, which allows for good qualimetry of analytical procedures. In this way, we established the approach's ability to perform a full validation of the analytical technique as well as its ability to estimate measurement uncertainty in a simple and uncomplicated way with minimum effort, utilizing only the data collected during the analytical validation.

Results: The findings suggest that this technique can properly assess the validity of the HPLC method for simultaneous determination of 22 amines, with 67-90% of compliance results falling within acceptable limits.

Conclusion: Using the uncertainty profile methodology, the full validation of an HPLC method for the determination of 22 azo amines in a textile matrix was successfully established.

Highlights: The development and evaluation of an efficient HPLC technique for the simultaneous determination of 22 azo amines in a textile matrix have been completed. The total reliability of the analytical procedure was established by evaluating its measurement uncertainty at each concentration level using the suggested uncertainty profile approach and confirming proportions 67 to 90% of compliance.