Artículos de revistas
Validation For Chromatographic And Electrophoretic Methods [validação Em Métodos Cromatográficos E Eletroforéticos]
Registro en:
Quimica Nova. , v. 27, n. 5, p. 771 - 780, 2004.
1004042
2-s2.0-27744536684
Autor
Ribani M.
Grespan Bottoli C.B.
Collins C.H.
Fontes Jardim I.C.S.
Costa Melo L.F.
Institución
Resumen
The validation of an analytical method is fundamental to implementing a quality control system in any analytical laboratory. As the separation techniques, GC, HPLC and CE, are often the principal tools used in such determinations, procedure validation is a necessity. The objective of this review is to describe the main aspects of validation in chromatographic and electrophoretic analysis, showing, in a general way, the similarities and differences between the guidelines established by the different Brazilian and international regulatory agencies. 27 5 771 780 (1995) Criteria for Evaluating Acceptable Methods of Analysis for Codex Purposes, , CX/MAS 95/3 (1995) Validation of Analytical Procedures: Definitions and Terminology, , International Conference on Harmonisation (ICH) Q2A (CPMP/ICH/381/95) (1995) Validation of Analytical Procedures: Methodology, , International Conference on Harmonisation (ICH) Q2B (CPMP/ICH/281/95) Resolução RE no899, , de 29/05/2003 (2001) Guidance for Industry, Bioanalytical Method Validation (2000) Guidance for Industry, Analytical Procedures and Methods Validation (1994) Reviewer Guidance, Validation of Chromatographic Methods (2000) Guidance Document on Residue Analytical Methods, , SANCO/825/00 (1998) The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics Thompson, M., Ellison, S.L.R., Wood, R., (2002) Pure Appl. Chem., 74, p. 835 (2003) Orientações Sobre Validação de Métodos de Ensaios Químicos, , DOQ-CGCRE-008 Shabir, G.A., (2003) J. Chromatogr., A, 987, p. 57 (1999) General Requirements for the Competence of Testing and Calibration Laboratories, , ISO/IEC 17025 (1999) US Pharmacopeia 24, , Validation of Compendial Methods 〈1225〉, Rockville Thirty-second report (1992) WHO Technical Report Series, 823. , Geneva Huber, L., (1998) LC-GC Int., 11, p. 96 Jenke, D.R., (1997) Instrument. Sci. Technol., 25, p. 345 Jenke, D.R., (1998) Instrument. Sci. Technol., 26, p. 1 Jenke, D.R., (1998) Instrument. Sci. Technol., 26, p. 19 Bruce, P., Minkkinen, P., Riekkola, M.L., (1998) Mikrochim. Acta, 128, p. 93 Massart, D.L., Smeyers-Verbeke, J., Vandeginste, B., (1994) Analusis, 22, pp. M14 Swartz, M.E., Krull, I.S., (1998) Pharm. Technol., 2, p. 12 Leite, F., (2002) Validação Em Análise Química, 4 a Ed., , Editora Átomo: Campinas Snyder, L.R., Kirkland, J.J., Glajch, J.L., (1997) Practical HPLC Method Development, 2 a Ed., , Wiley: New York, cap. 15 Hill, A.R.C., Reynolds, S.L., (1999) Analyst, 124, p. 953 Van Der Voet, H., Van Rhijn, J.A.H., Van De Wiel, H.J., (1999) Anal. Chim. Acta, 391, p. 159 Horwitz, W., (1995) Pure Appl. Chem., 67, p. 331 (1994) Precision of Test Methods, , ISO 5725 Krull, I., Swartz, M., (1998) LC-GC, 16, p. 464 (1993) Review Guide: Validation of Chromatographic Methods, , Rockville (1987) General Principles of Validation, , Rockville Vessman, J., Stefan, R.I., Staden, J.F.V., Danzer, K., Lindner, W., Burns, D.T., Fajgelj, A., Müller, H., (2001) Pure Appl. Chem., 73, p. 1381 Augusto, F., Andrade, J.C., Custódio, R., http://www.chemkeys.comBarros Neto, B., Pimentel, M.F., Araújo, M.C.U., (2002) Quim. Nova, 25, p. 856 Custodio, R., De Andrade, J.C., Augusto, F., (1997) Quim. Nova, 20, p. 219 Chui, Q.S.H., Zucchini, R.R., Lichtig, J., (2001) Quim. Nova, 24, p. 374 Barros Neto, B., Scarminio, I.S., Bruns, R.E., (2001) Como Fazer Experimentos: Pesquisa e Desenvolvimento Na Ciência e Na Indústria, , Editora da Unicamp: Campinas Green, J.M., (1996) Anal. Chem., 68, pp. A305 (1999) Manual de Resíduos de Pesticidas Em Alimentos, , Apostila Krull, I., Swartz, M., (1998) LC-GC, 16, p. 1084 Cuadros-Rodríguez, L., Gámiz-Gracia, L., Almansa-López, E.M., Bosque-Sendra, J.M., (2001) Trends Anal. Chem., 20, p. 620 Lanças, F.M., (1993) Cromatografia Em Fase Gasosa, , Acta: São Carlos Egea-González, F.J., Torres, M.E.H., López, E.A., Cuadros-Rodríguez, L., Vidal, J.L.M., (2002) J. Chromatogr., A, 966, p. 155 Cuadros-Rodríguez, L., Garcia-Campaña, A.M., Almansa-López, E.M., Egea-González, F.J., Cano, M.L.C., Frenich, A.G., Martinez-Vidal, J.L., (2003) Anal. Chim. Acta, 478, p. 281 Berg, R.G., Murta, A.L.M., Kugler, W., (1988) Quim. Nova, 11, p. 288 (2000) Vocabulário Internacional de Termos Fundamentais e Gerais de Metrologia, 2 a Ed. Vial, J., Jardy, A., (2001) Chromatographia, 53, pp. S-141 Horwitz, W., Kamps, L.R., Boyer, K.W., (1980) J. Assoc. Offic. Anal. Chem., 63, p. 1344 (1993) Statistics-Vocabulary and Symbols-Part 1: Probability and General Statistical Terms, , ISO 3534-1 Thompson, M., Ellison, S.L.R., Fajgelj, A., Willetts, P., Wood, R., (1999) Pure Appl. Chem., 71, p. 337 Burns, D.T., Danzer, K., Townshend, A., (2002) Pure Appl. Chem., 74, p. 2201 De Andrade, J.C., (1987) Quim. Nova, 10, p. 159 Miller, J.C., Miller, J.N., (1988) Statistics for Analytical Chemistry, 2 a Ed., , Ellis Horwood: Chichester Box, G.E.P., Hunter, W.G., Hunter, J.S., (1987) Statistics for Experimenters, , Wiley: New York Heyden, Y.V., (1994) Analusis, 22, pp. M27