Using Design Space and Response Surface Methodology for developing a liquid chromatography method for simultaneous determination of five statins in pharmaceutical form

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 min1 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.