Youden’s test of the chromatographic determination of captopril in pharmaceuticals

Abstract

Introduction: Robustness tests were originally introduced to avoid problems in interlaboratory studies and to identify the potentially responsible factors. This means that a robustness test was performed at a late stage in the method validation since interlaboratory studies are performed in the final stage. Thus, the robustness test was considered a part of method validation related to the precision (reproducibility) determination of the method. However, performing a robustness test late in the validation procedure involves the risk that when a method is found not to be robust, it should be redeveloped and optimized. At this stage, much effort and money have already been spent in the optimization and validation, and therefore one wants to avoid this. The aim of this study was to evaluate the rubustness of ultra-high-performance liquid chromatography (UHPLC) determination of captopril in tablets using Youden’s test. Materials and Methods: An efficient method to assess the robustness of analytical methods is by Youden’s test, by means of an experiment design which involves seven analytical parameters combined in eight tests. In the recent studies, we assessed the robustness of a chromatographic method to quantify captopril in tablets using Youden’s test. Results: Using the Youden’s test criteria, UHPLC method showed to be greatly robust concerning captopril content, at the introduction of variation in seven analytic parameters. The highest variation in captopril content was 0.96%, when was used column Nucleosil C18 (4.6 mm × 150 mm with a particle size of 5 μ). Using column Ascentis Express C18 Fused-Core® technology (column size 4.6 mm × 150 mm with a particle size of 5 μ) reduces the retention time of captopril more than 2 times. Conclusion: Youden’s test proved to be an efficient and helpful tool for the robustness evaluation for assay of captopril by UHPLC.