Pre-study and in-study validation of an ultra-high pressure LC method coupled to tandem mass spectrometry for off-line determination of oxytetracycline in nasal secretions of healthy pigs

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 877, Issue 23, 2009, Pages 2349-2357

  Bimazubute, M A ^a   Rozet, E ^a   Dizier, I ^a   Van Heugen, J Cl ^b   Arancio, E ^b   Gustin, P ^a   Crommen, J ^a   Chiap, P ^b  

^a UNIVERSITY OF LIÈGE   (Belgium)

^b Academic Hospital of Liege   (Belgium)

Author keywords

Healthy pigs; Nasal secretions; Oxytetracycline; Uncertainty; UPLC MS MS; Validation

Indexed keywords

HEALTHY PIGS; NASAL SECRETIONS; OXYTETRACYCLINE; UNCERTAINTY; UPLC-MS/MS; VALIDATION;

ACETONITRILE; CHROMATOGRAPHIC ANALYSIS; ELECTROSPRAY IONIZATION; FORMIC ACID; MASS SPECTROMETERS; MASS SPECTROMETRY; ORGANIC ACIDS; RISK PERCEPTION; UNCERTAINTY ANALYSIS;

HIGH PRESSURE LIQUID CHROMATOGRAPHY;

FORMIC ACID; METACYCLINE; OXALIC ACID; OXYTETRACYCLINE;

ARTICLE; CHEMICAL REACTION; CHEMICAL STRUCTURE; CONTROLLED STUDY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; NONHUMAN; NOSE SECRETION; PRIORITY JOURNAL; SWINE; TANDEM MASS SPECTROMETRY; TEMPERATURE MEASUREMENT; VALIDATION PROCESS;

ANIMALS; ANTI-BACTERIAL AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; NASAL MUCOSA; OXYTETRACYCLINE; SWINE; TANDEM MASS SPECTROMETRY;

SUIDAE;

EID: 67650444806     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2009.01.033     Document Type: Article

References (35)

1. Hall W.F., Kniffen T.S., Bane D.P., Bevill R.F., and Koritz G.D. JAVMA 194 (1989) 1265
2. Pijpers A., Schoevers E.J., van Gogh H., van Leengoed L.A.M.G., Visser I.J.R., van Miert A.S.J.P.A.M., and Verheiden J.H.M. J. Vet. Pharmacol. Ther. 13 (1990) 320
3. Nielsen P., and Gyrd-Hansen N. J. Vet. Pharmacol. Ther. 19 (1996) 305
4. de A., Banting L., and Baggot J.D. J. Vet. Pharmacol. Ther. 19 (1996) 50
5. El Korchi G., Prats G., Arboix M., and Pérez B. J. Vet. Pharmacol. Ther. 24 (2001) 247
6. Bimazubute M.A., Rozet E., Dizier I., Gustin P., Hubert Ph., Crommen J., and Chiap P. J. Chromatogr. A 1189 (2008) 456
7. Oka H., Ito Y., and Matsumoto H. J. Chromatogr. A 882 (2000) 109
8. Anderson C.R., Rupp H.S., and Wu W.-H. J. Chromatogr. A 1075 (2005) 23
9. Koesukwiwat U., Jayanta S., and Leepipatpiboon N. J. Chromatogr. A 1140 (2007) 147
10. L. Janssen, M. Bimazubute, M.-P. Liardet, P. Gustin, J. Mainil, Poster presented at the "2ème Colloque Francophone de Bactériologie Vétérinaire", ISPAIA, AFSSA, Ploufragan, France, September 2002.
11. L.R. Snyder, J.W. Dolan, in: High-performance Gradient Elution, The Practical Application of the linear-solvent-strength Mod, January 2007.
12. Xu R.N., Fan L., Rieser M.J., and El-Shourbagy T.A. J. Pharm. Biomed. Anal. 44 (2007) 342
13. M. Bimazubute, P. Gustin, P. Chiap, Poster presented at the 15th International Symposium on Pharmaceutical and Biomedical Analysis, Florence, Italy, PBA 2004.
14. International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005.
15. Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
16. ISO/CEI 17025: General requirements for the competence of testing and calibration laboratories, International Organization for Standardization (ISO), Geneva, 2000.
17. ISO Medical laboratories: particular requirements for the competence of testing and calibration laboratories, International Organization for Standardization (ISO), Geneva, 2003.
18. 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
19. 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. Prat. 13 (2003) 101
20. 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
21. 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 Prat. 16 (2006) 28
22. Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., and Rozet E. J. Pharm. Biomed Anal. 45 (2007) 82
23. Rozet E., Wascotte V., Lecouturier N., Préat V., Dewé W., Boulanger B., and Hubert Ph. Anal. Chim. Acta 591 (2007) 239
24. Rozet E., Hubert C., Ceccato A., Dewé W., Ziemons E., Moonen F., Michail K., Wintersteiger R., Streel B., Boulanger B., and Hubert Ph. J. Chromatogr. A 1158 (2007) 126
25. Process Analytical Technology (PAT) Initiative, US Food and Drug Administration, Rockville, MD, 2004; http://www.fda.gov/cder/OPS/PAT.htm.
26. International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, 2005; http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf.
27. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., and Weiner R. AAPS J. 9 (2007) E30. http://www.aapsj.org
28. Boulanger B., Dewe W., Gilbert A., Govaerts B., and Maumy-Bertrand M. Chemometr. Intell. Lab. Syst. 86 (2007) 198
29. ISO 5725 parts 1-6, Accuracy (trueness and precision) of measurement methods and results, International Organization for Standardization (ISO), Geneva, 1994.
30. Rozet E., Ceccato A., Hubert C., Ziemons E., Oprean R., Rudaz S., Boulanger B., and Hubert Ph. J. Chromatogr. A 1158 (2007) 111
31. Miller J.C., and Miller J.N. Statistics for Analytical Chemistry. 3rd ed. (1993), Elli Horwood, New York
32. Feinberg M., Boulanger B., Dewé W., and Hubert Ph. Anal. Bioanal. Chem. 380 (2004) 502
33. Analytical Methods Committee. Analyst 120 (1995) 2303
34. Eurachem/Citac guide "Quantifying the Uncertainty in Analytical Measurement", 2nd ed., 2000.
35. EA-4/16, EA Guidelines on the Expression of Uncertainty in Quantitative Testing, 2004; http://www.european-accreditation.org.