Ruggedness and robustness testing

Abstract

Due to the strict regulatory requirements, especially in pharmaceutical analysis, analysis results with an acceptable quality should be reported. Thus, a proper validation of the measurement method is required. In this context, ruggedness and robustness testing becomes increasingly more important. In this review, the definitions of ruggedness and robustness are given, followed by a short explanation of the different approaches applied to examine the ruggedness or the robustness of an analytical method. Then, case studies, describing ruggedness or robustness tests of high-performance liquid chromatographic (HPLC), capillary electrophoretic (CE), gas chromatographic (GC), supercritical fluid chromatographic (SFC), and ultra-performance liquid chromatographic (UPLC) assay methods, are critically reviewed and discussed. Mainly publications of the last 10 years are considered.