Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC Recommendations 1995)

It is internationally recognized that validation is necessary in analytical laboratories. The use of validated methods is important for an analytical laboratory to show its qualification and competency. In this update on analytical quality, we place validation of analytical methodologies in the broader context of quality assurance (QA). We discuss different approaches to validation, giving attention to the different characteristics of method performance. We deal with the concepts of single-laboratory or in-house validation, inter-laboratory or collaborative study, standardization, internal quality control (IQC), proficiency testing (PT), accreditation and, finally, analytical QA (AQA). This article provides a good, complete, up-to-date collation of relevant information in the fields of analytical method validation and QA. It describes the different aspects of method validation in the framework of QA. It offers insight and direct help to anyone involved in any analytical methodologies, whether they are an academic researcher or in the industrial sector.

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Trends in quality in the analytical laboratory. II. Analytical method validation and quality assurance

Nomenclature in evaluation of analytical methods including detection and quantification capabilities1: (IUPAC Recommendations 1995)

The limit of detection (LOD) and the sensitivity of a chemical sensor are defined using IUPAC guidelines. The LOD from simulated and experimental data is calculated from a calibration curve using a simple statistical model that was implemented into a spreadsheet program. This definition of the LOD is compared with the commonly used definition of the LOD, which is based on the product of sensitivity and the theoretical instrument resolution.

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Detection Limits of Chemical Sensors: Applications and Misapplications

Neste trabalho sao apresentadas as definicoes dosparâmetros (seletividade, limites de deteccao equantificacao, exatidao, precisao, linearidade, graficoanalitico, sensibilidade e robustez) considerados nosprocessos de validacao de metodos analiticos. Aestrategia a ser adotada para a determinacao dessesparâmetros depende do proposito e da natureza dometodo. Exemplos sao apresentados para aavaliacao dos parâmetros no procedimento devalidacao. ANALYTICAL METHODS VALIDATION: STRATEGY AND DISCUSSION Abstract This paper presents the definitions of the parameters (selectivity, limits of detection and quantification, accuracy, precision,linearity, analytical graphic, sensitivity and ruggedness) considered on analytical methods validation procedures. The strategy to be adopted for determinations of these parameters depends on the purpose and the nature of the method.Some examples are presented for parameters evaluation in a validation procedure.

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Validação de métodos analíticos: estratégia e discussão

Chairman: G. Svehla (UK), Secretary: S . P. Perone (USA). Titular Members: C. A. M. G. Cramers (Netherlands), R. W. Frei (Netherlands), R. E. van Grieken (Belgium), D. Klockow (FRG). Associate Members: L. Currie (USA), L. S . Ettre (USA), A. Fein (USA), H. Freiser (USA), W. Horwitz (USA), M. A. Leonard (UK), D. Leyden (USA), R. F. Martin (USA), B. Schreiber (Switzerland). National Representatives: K. Doerffel (GDR), I. Giolito (Brazil), E. Grushka (Israel), W. E. Harris (Canada), H. M. N. H. Irving ( S . African Republic), D. Jagner (Sweden), W. Rosset (France), J. Stary (Czechoslovakia).

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Gyula Svehla

Papers

Nomenclature for the presentation of results of chemical analysis (IUPAC Recommendations 1994)