221-242. By far the most A third definition proposes that this analytical parameter is “the capacity of an analytical procedure to remain unaffected by small but deliberately introduced variations in method parameters and provides an indication of its reliability during normal usage” . Definition Analytical Chemistry can be defined in four simple ways as: (1) the discipline in charge of “Analysis” (the fourth component of Chemistry in addition to Theory, Synthesis and ... Robustness in an analytical method is the resistance to change in its results when applied 44 Analytical Chemistry 2.0 Finally, a protocol is a set of stringent guidelines specifying a proce-dure that must be followed if an agency is to accept the results. Robustness and ruggedness are frequently confused and interrelated. different column makes. Robustness is the capacity of a method to remain unaffected by … This work implies that these chemistries may be significantly more robust in the digital, rather than kinetic, format. Note: Ideally, robustness should be explored during the development of the assay method. 9. Robustness testing deals with the critical operational parameters and the tolerances for their control. Method validation is a key element in the establishment of reference methods and within the assessment of a laboratory’s competence in generating dependable analytical records. Robustness is a term that is commonly used in publications dealing with method validation. Robustness and Outlier Detection in Chemometrics. Flow rate. It also calls for theoretical studies to predict robustness of these chemistries and, more generally, to design robust reaction architectures. pH of mobile phase. When it is transposed into a system, it refers to the ability of tolerating perturbations that might affect the system’s functional body. 36, No. Critical Reviews in Analytical Chemistry: Vol. ROBUSTNESS ROBUSTNESS of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage. Also see: Analytical Method Validation Examples of typical variations are : Stability of analytical solutions. Validation has been placed within the context of the procedure, generating chemical data. 3-4, pp. developed, but their robustness is not well understood. extraction time. Robustness It is the reliability of an analysis with respect to deliberate variations in method parameters. Robustness is the property of being strong and healthy in constitution. MASSART ChemoA C, Pharmaceutical Institute, Vro'e Universiteit Brussel, (2006). 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