Ruggedness and robustness testing.
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.
Dejaegher
Bieke
B
Analytical Chemistry and Pharmaceutical Technology, Pharmaceutical Institute, Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium.
Heyden
Yvan Vander
YV
D002849:Chromatography, Gas / Q000592:standards*; D002851:Chromatography, High Pressure Liquid / Q000592:standards*; D025924:Chromatography, Supercritical Fluid / Q000592:standards*; D019075:Electrophoresis, Capillary / Q000592:standards*; D015203:Reproducibility of Results