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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Format: | Article |
Language: | English |
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Sociedade Brasileira de Química
2009-01-01
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Series: | Química Nova |
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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. |
first_indexed | 2024-12-11T11:37:19Z |
format | Article |
id | doaj.art-9c1260cbcdc74baa8192f5fcdfa6a6b6 |
institution | Directory Open Access Journal |
issn | 0100-4042 1678-7064 |
language | English |
last_indexed | 2024-12-11T11:37:19Z |
publishDate | 2009-01-01 |
publisher | Sociedade Brasileira de Química |
record_format | Article |
series | Química Nova |
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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