Performances of a multidimensional on-line SPE-LC-ECD method for the determination of three major catecholamines in native human urine: Validation, risk and uncertainty assessments
[en] A novel, multidimensional on-line SPE-LC method with electrochemical detection is described for the fully automated and direct analysis of the catecholamines norepinephrine, epinephrine and dopamine in urine. The integrated extractive clean-up of the raw biofluid is based on a SPE-column packed with restricted access material (RAM) which is modified with the affinity ligand nitrophenylboronic acid. The method was fully validated according to a recent approach based on an accuracy profile. The acceptance limits were set at +/- 15% of the nominal concentration values. The method was found accurate over a concentration range from 15 to 500 mu g/l for norepinephrine, from 5 to 500 mu g/l for epinephrine and from 50 to 500 mu g/l for dopamine. The relative risk for the use of the validated method in routine analysis was also assessed based on this validation strategy. It was found that at most 3.5% of future sample measurements will fall outside the acceptance limits. This demonstrates the high reliability of the analytical method described. Moreover, the measurements uncertainties were deduced from the validation experiments without any additional effort. (c) 2006 Elsevier B.V. All rights reserved.
Performances of a multidimensional on-line SPE-LC-ECD method for the determination of three major catecholamines in native human urine: Validation, risk and uncertainty assessments
Publication date :
05 December 2006
Journal title :
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
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Bibliography
Corcuff J.-B., Monsaingeon M., Gatta B., and Simonnet G. IBS 17 (2002) 293
Fischer D.H., Fischer L.M., and Broudy M. J. Liq. Chromatogr. 18 (1995) 3311
Candito M., Bree F., and Krstulovic A.M. Biomed. Chromatogr. 10 (1996) 40
Wang Y., Fice D.S., and Yeung P.K.F. J. Pharm. Biomed. Anal. 21 (1999) 519
Grossi G., Bargossi A.M., and Sprovieri G. Chromatographia 36 (1993) 110
Yamasaki H., Miyanaga A., and Umino M. Chromatographia 20 (1999) 202
Raggi M.A., Sabbioni C., Casamenti G., Gerra G., Calonghi N., and Masotti L. J. Chromatogr. B 730 (1999) 201
Raggi M.A., Sabbioni C., Nicoletta G., Mandrioli R., and Gerra G. J. Sep. Sci. 26 (2003) 1141
Chan E.C.Y., Wee P.Y., and Ho P.C. J. Pharm. Biomed. Anal. 22 (2000) 515
Pastoris A., Cerutti L., Sacco R., De Vecchi L., and Sbaffi A. J. Chromatogr. B: Biomed. Appl. 664 (1995) 287
Sabbioni C., Saracino M.A., Mandrioli R., Pinzauti S., Furlanetto S., Gerra G., and Raggi M.A. J. Chromatogr. A 1032 (2004) 65
Tsuchiya H., and Hayashi T. J. Pharmacol. Methods 23 (1990) 21
Hollenbach E., Shulz C., and Lehnert H. Life Sci. 63 (1998) 737
Brandsteterova E., Kubalec P., Skacani I., and Balazovjech I. Neoplasma 41 (1994) 205
Seki T., Yanagihara Y., and Noguchi K. J. Chromatogr. 515 (1990) 435
Mashige F., Matsushima Y., Miyata C., Yamada R., Kanazawa H., Sakuma I., Takai N., Shinozuka N., Ohkubo A., and Nakahara K. Biomed. Chromatogr. 9 (1995) 221
Grossi G., Bargossi A.M., Lucarelli C., Paradisi R., Sprovieri C., and Provieri G. J. Chromatogr. 541 (1991) 273
Grossi G., Bargossi A.M., Lippi A., and Battistoni R. Chromatographia 24 (1987) 842
Brandsteterova E., Kubalec P., Krajnak K., and Skacani I. Neoplasma 43 (1996) 107
Boos K.S., Wilmers B., Schlimme E., and Sauerbrey R. J. Chromatogr. 456 (1988) 93
Soga T., and Inoue Y. J. Chromatogr. 620 (1993) 175
Hansen A.M., Kristiansen J., Nielsen J.L., Byrialsen K., and Christensen J.M. Talanta 50 (1999) 367
Rudolphi A., Boos K.-S., and Seidel D. Chromatographia 41 (1995) 645
Boos K.-S., Wilmers B., Sauerbrey R., and Schlimme E. Chromatographia 24 (1987) 363
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. STP Pharma Pratiques 13 (2003) 101
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. J. Pharm. Biomed. Anal. 36 (2004) 579
Boulanger B., Chiap P., Dewe W., Crommen J., and Hubert Ph. J. Pharm. Biomed. Anal. 32 (2003) 753
Marini R.D., Chiap P., Boulanger B., Rudaz S., Rozet E., Crommen J., and Hubert Ph. Talanta 68 (2006) 1166
Morello R., Boos K.-S., and Seidel D. G.I.T. Lab. J. Europe 6 (2004) 30
In: Guder W.G., Narayanan S., Wisser H., and Zawta B. (Eds). Samples: From the Patient to the Laboratory (2003), Wiley-VCH, Weinheim 106
Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. STP Pharma Pratiques 16 (2006) 30
Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), May 2001.
Shah V.P., Midha K.K., Dighe S., McGilveray I.J., Skelly J.P., Yacobi A., Layloff T., Viswanathan C.T., Cook C.E., McDowall R.D., Pittman K.A., and Spector S. J. Pharm. Sci. 81 (1992) 309
Shah V.P., Midha K.K., Findlay J.W.A., Hill H.M., Hulse J.D., McGilveray I.J., McKay G., Miller K.J., Patnaik R.N., Powell M.L., Tonelli A., Viswanathan C.T., and Yacobi A. Pharm. Res. 17 (2000) 1551
Hubert Ph., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce P., Lallier M., Laparra M.C., Laurentie M., and Nivet J.C. Anal. Chim. Acta 391 (1999) 135
ISO 5725-1, Application of the statistics-accuracy (trueness and precision) of the results and methods of measurement. Part 1. General principles and definitions, International Organization for Standardization (ISO), Geneva, Switzerland.
Chow S.C., and Liu J.P. Statistical Design and Analysis in Pharmaceutical Sciences: Validation, Process Controls and Stability, Statistics Textbooks and Monographs vol.143 (1995), Marcel Dekker, New York
Marini R.D., Servais A.-C., Rozet E., Chiap P., Boulanger B., Rudaz S., Crommen J., Hubert Ph., and Fillet M. J. Chrom. A 1120 (2006) 102
Food and Drug Administration. Process Analytical Technology (PAT) Initiative (2004). http://www.fda.gov/cder/OPS/PAT.htm
Feinberg M., Boulanger B., Dewé W., and Hubert Ph. Anal. Bioanal. Chem. 380 (2004) 502
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