Warianty tytułu
Validation method for determination of 8-alfa-hydroxymutilin in biological material
Języki publikacji
Abstrakty
A validation method is a key element in both the elaboration of reference methods and the assessment of a laboratory's competence in producing reliable analytical data. The aim of the study was to validate the GC method (according to Marcus and Sherma), which is used in determining 8-α-hydroxymutilin in a biological matrix (swine tissues: liver and muscles). The fundamental parameters for validation, including accuracy, precision, selectivity, sensivity, reproductibility and stability, were estimated. The studies confirmed the usefulness of the GC method for determining tiamulin residues in swine tissues.
Wydawca
Czasopismo
Rocznik
Tom
Numer
Strony
797-800
Opis fizyczny
s.797-800,rys.,tab.,bibliogr.
Twórcy
autor
- Akademia Rolnicza, ul.Akademicka 12, 20-033 Lublin
autor
autor
Bibliografia
- 1.Anon.: Freedom of Information Office, Center for Veterinary Medicine, Supplement to NADA 139-472, Environmental Assessment, Denagard® (tiamulin) Premixes, July 1988.
- 2.Anon.: Guidance for Industry, Bioanalytical Method Validation. FDA, Center for Drug valuation and Research, CVM, May 2001.
- 3.Anon.: Joint FAO/WHO Expert on Food Additives: Evaluation of certain veterinary drug residues in food. World Health Organisation, Technical Report, Geneva, Series 763 (32), 1988.
- 4.Anon.: Komisja Rejestracji środków Farmaceutycznych i Materiałów Medycznych. Materiały, Wyd. I, Warszawa 1997.
- 5.Anon.: Note for Guidance: Approach Towards Harmonisation of Withdrawal Periods. EMEA/CVMP/036/95-Final, March 1996.
- 6.Anon.: Note for guidance on the risk analysis approach for residues of veterinary medicinal products in food of animal origin. EMEA/CVMP/187/00-Final, 2001.
- 7.Anon.: Tiamulin Summary Report (3). Committee for Veterinary Medicinal Products EMEA/MRL/747/00-Final, July 2000.
- 8.Hibbert D.: Method validation of modern analytical techniques. Accred Qual Assur, 1999, 4, 352-356.
- 9.Marcus J., Sherma J.: Method IV. Gas chromatographic determination of tiamulin residues in swine liver. J. AOAC Int. 1993, 76, 451-458.
- 10.Marcus J., Sherma J.: Method V. Gas chromatographic/ mass spectro metric confirmation of 8-hydroxymutilin, a tiamulin metabolite, in swine liver extracts. J. AOAC Int. 1993, 76, 459-460.
- 11.Piskorska-Pliszczyńska J.: Walidacja metod badawczych - wymagania, zalecenia i praktyka. Medycyna Wet. 2002, 58, 827-831.
- 12.Rödel W., Wölm G.: Chromatografia gazowa. Wyd. Nauk. PWN, Warszawa 1992.
- 13.Shah V., Midha K., Findlay J., Hill H., Hulse J., McGilveray I., McKay G., Miller K., Patnaik R., Powell M., Tonelli A., Viswanathan C., Yacobi A.: Bioanalytical method validation - a revisit with a decade of progress. Pharmaceut. Res. 2000, 17, 1551-1557.
- 14.Trullols E., Ruisanchez I., Ruis F.: Validation of qualitative analytical methods. Trends Anal. Chem. 2004, 23, 137-145.
Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
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