Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces

<abstract language="eng">A cleaning validation method was developed and validated, based on swabbing sampling and simultaneous chromatographic determination of sulfamethoxazole (SMX) and trimethoprim (TMP) residues. The method presented limits of detection of 0.06 mg mL-1 for SMX and...

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Main Authors: Roberto C. Coutinho, Elder T. Barbosa, Marcelo M. Sena, Caridad Noda Pérez
Format: Article
Language:English
Published: Sociedade Brasileira de Química 2009-01-01
Series:Química Nova
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422009000800038
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author Roberto C. Coutinho
Elder T. Barbosa
Marcelo M. Sena
Caridad Noda Pérez
author_facet Roberto C. Coutinho
Elder T. Barbosa
Marcelo M. Sena
Caridad Noda Pérez
author_sort Roberto C. Coutinho
collection DOAJ
description <abstract language="eng">A cleaning validation method was developed and validated, based on swabbing sampling and simultaneous chromatographic determination of sulfamethoxazole (SMX) and trimethoprim (TMP) residues. The method presented limits of detection of 0.06 mg mL-1 for SMX and 0.09 mg mL-1 for TMP. It was considered selective, precise, accurate and robust according to the guidelines from ANVISA, the Brazilian regulatory agency, and International Conference on Harmonization. Mean swab recovery factors of 98.5% for SMX and 97.7% for TMP were obtained for spiked stainless steel plates. The method was successfully applied to the assay of actual swab samples collected from eleven points on an equipment surface.
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spelling doaj.art-9c1260cbcdc74baa8192f5fcdfa6a6b62022-12-22T01:08:43ZengSociedade Brasileira de QuímicaQuímica Nova0100-40421678-70642009-01-013282214221710.1590/S0100-40422009000800038Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfacesRoberto C. CoutinhoElder T. BarbosaMarcelo M. SenaCaridad Noda Pérez<abstract language="eng">A cleaning validation method was developed and validated, based on swabbing sampling and simultaneous chromatographic determination of sulfamethoxazole (SMX) and trimethoprim (TMP) residues. The method presented limits of detection of 0.06 mg mL-1 for SMX and 0.09 mg mL-1 for TMP. It was considered selective, precise, accurate and robust according to the guidelines from ANVISA, the Brazilian regulatory agency, and International Conference on Harmonization. Mean swab recovery factors of 98.5% for SMX and 97.7% for TMP were obtained for spiked stainless steel plates. The method was successfully applied to the assay of actual swab samples collected from eleven points on an equipment surface.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422009000800038HPLCcleaning validationswabbing recovery
spellingShingle Roberto C. Coutinho
Elder T. Barbosa
Marcelo M. Sena
Caridad Noda Pérez
Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces
Química Nova
HPLC
cleaning validation
swabbing recovery
title Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces
title_full Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces
title_fullStr Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces
title_full_unstemmed Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces
title_short Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces
title_sort determinacao simultanea de residuos de sulfametoxazol e trimetoprima em superficies de equipamentos de producao simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces
topic HPLC
cleaning validation
swabbing recovery
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422009000800038
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AT eldertbarbosa determinacaosimultaneaderesiduosdesulfametoxazoletrimetoprimaemsuperficiesdeequipamentosdeproducaosimultaneousdeterminationofsulfamethoxazoleandtrimethoprimresiduesonmanufacturingequipmentsurfaces
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