This study describes the development of a method allowing the simultaneous separation and quantification of five statins by High performance liquid chromatography/Diode Array Detector (HPLC/DAD). Optimization was accomplished using chemometric tools such as the Design Space (DS) and Response Surface Methodology (RSM). Central Composite Design (CCD) and DS were applied for the optimization of the chromatographic procedure as well as the robustness of the chromatographic method by taking the ratio of the percentage of acetonitrile (%ACN) Buffer solution, the pH and the mobile phase flow rate as critical parameters. Satisfactory results were obtained after the optimization phase with a percentage of mobile phase equal to 46.19%, a pH of 4.16 and the flow rate is 1.4 mL min−1 by setting the resolution limits above 6, and the target retention time of 20 min. Using the DS and CCD approach, we have developed a robust and reliable procedure for the simultaneous and accurate separation and quantification of the five statins.

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Background Azo dyes are synthetic dyes that might emit 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. Method The HPLC-DAD 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 qualimetric 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 the 22 amines, with 67-90 percent of compliance results falling within acceptable limits. Conclusions 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 well established by evaluating its measurement uncertainty at each concentration level using the suggested uncertainty profile approach and confirming proportions 67 to 90% of compliance.