Improvement of peak shape using a custom injection program.

Introduction of case studies using the Vanquish Core HPLC system for routine analysis.

To ensure sufficient performance of the chromatographic system, the system suitability test (SST) requires the injection of standard samples and evaluation according to the procedure manual. The European Pharmacopoeia (EP) general chapter (Chromatographic Separation Techniques 2.2.46) defines the acceptable deviations for EP methods. Particularly, since only slight changes are permitted under gradient conditions, it is crucial to ensure that sufficient results are obtained with the original method. In high-performance liquid chromatography (HPLC), minimizing the system's dead volume can lead to a mismatch between the sample solvent and the initial gradient composition, resulting in inadequate mixing and the appearance of front peaks or split peaks. Therefore, a custom injection program can be used to reduce the impact of the injection solvent without changing the injection volume or the solvent used to dissolve the sample. This document demonstrates the usefulness of the custom injection program for meeting system suitability criteria such as symmetry, resolution, and efficiency, without altering the EP method for mebendazole.

Analytical Equipment and Devices