Romanian Society of Pharmaceutical Sciences

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METHOD VALIDATION FOR SIMULTANEOUS DETERMINATION OF 12 SULFONAMIDES IN HONEY USING BIOCHIP ARRAY TECHNOLOGY

IONELA DANIELA POPA (MORARIU)1, ELENA-CORINA SCHIRIAC2, SIMONA MATIUT2, RODICA CUCIUREANU1

1University of Medicine and Pharmacy “Gr. T. Popa”, Faculty of Pharmacy, Department of Environmental and Food Chemistry, Iasi, 16, Universităţii st., 700115, Romania
2Investigatii Medicale Praxis, Iasi, 33, Independenţei st., 700102, Romania

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A new method for simultaneous multi-analyte determination of drug residues in honey samples was validated according to the criteria set by the Commission Decision 2002/657/EC. “Antimicrobial Array I”, An immunoassay based on multi-analyte array for drug residues testing has been evaluated for simultaneous screening of twelve sulphonamides (sulphamethazine, sulphadiazine, sulphadimethoxine, sulphaquinoxaline, sulphathiazole, sulphisoxazole, sulphapyridine, sulphamerazine, sulphamethoxypyridazine, sulphachlorpyridazine, sulphamethizole, sulphadoxine). The analytes determination was carried out using Biochip Array Technology, an immunoassay testing platform for the simultaneous multi-analyte assessment of a panel of tests, in a single test procedure, using a single undivided sample. The method showed good linearity, sensitivity, specificity, precision (repeatability and intra-laboratory reproductibility), ruggedness and recovery at three concentration levels representing 0.5, 1.0 respectively 1.5% from the maximum accepted residue limits (50, 100, and 150 μg/kg). The decision limits (CCα) were always below 0.5 % from the maximum residue limits (MRL). The results of the validation protocol showed that the method complies with a performant European Union monitoring of drug residues in food. The developed procedure was applied to 16 honey samples, and for two of them there were detected residues of sulphonamides (sulphfadiazine, sulphametazine, sulphatiazol, sulphametizol).