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. 221-242. Temperature. Critical Reviews in Analytical Chemistry: Vol. (2006). Robustness and Outlier Detection in Chemometrics. 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 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. 36, No. By far the most Robustness. Robustness The 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. Robustness is the property of being strong and healthy in constitution. pH of mobile phase. Robustness and ruggedness are frequently confused and interrelated. Validation has been placed within the context of the procedure, generating chemical data. 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” . 3-4, pp. MASSART ChemoA C, Pharmaceutical Institute, Vro'e Universiteit Brussel, It also calls for theoretical studies to predict robustness of these chemistries and, more generally, to design robust reaction architectures. Also see: Analytical Method Validation Robustness is a term that is commonly used in publications dealing with method validation. Robustness is the capacity of a method to remain unaffected by … Robustness testing deals with the critical operational parameters and the tolerances for their control. Chapter 3 REVIEW OF THE USE OF ROBUSTNESS AND RUGGEDNESS IN ANALYTICAL CHEMISTRY Y. VANDER HEYDEN AND D.L. 9. developed, but their robustness is not well understood. extraction time. 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. different column makes. When it is transposed into a system, it refers to the ability of tolerating perturbations that might affect the system’s functional body. Robustness It is the reliability of an analysis with respect to deliberate variations in method parameters. Flow rate. This work implies that these chemistries may be significantly more robust in the digital, rather than kinetic, format. Examples of typical variations are : Stability of analytical solutions. ... accuracy, precision, sensitivity, selectivity, robustness, ruggedness, scale of operation, analysis time, availability of equipment, and cost. Note: Ideally, robustness should be explored during the development of the assay method.