| Registro completo |
| Provedor de dados: |
BJPS
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| País: |
Brazil
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| Título: |
Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril
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| Autores: |
Nogueira,Raquel
Wollinger,Wagner
Silva,Thaís Elias da
Oliveira,Leonardo Mesquita de
Rego,Eliane Cristina Pires do
Moreira,Gabriela Fernandes
Barin,Juliano Smanioto
Laporta,Luciane Varini
Mesko,Márcia Foster
Bittencourt,Celso Figueiredo
Rodrigues,Janaína Marques
Cunha,Valnei Smarçaro da
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| Data: |
2011-06-01
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| Ano: |
2011
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| Palavras-chave: |
Captopril/qualitative analysis
Medicines/analysis
Medicines/method validation
Medicines/analytical quality control
High performance liquid chromatography/qualitative analysis
Medicines/contamination
Captopril/certified reference standards
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| Resumo: |
This paper describes the validation of a reversed-phase high performance liquid chromatography method (RP-HPLC) with diode array detection (DAD) for determination of related substances (impurities from organic synthesis and degradation products) of captopril according to the Brazilian Pharmacopeia IV. The aim of this study was to guarantee the method accuracy for quantification of related substances, an essential requisite to determine, using the mass balance approach, the captopril content in the first Brazilian certified reference material (CRM) of an active pharmaceutical ingredient (API), developed by Inmetro. The captopril instability in solution is discussed and the captopril content determined by mass balance is compared to the results from titration and differential scanning calorimetry (DSC).
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| Tipo: |
Info:eu-repo/semantics/article
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| Idioma: |
Inglês
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| Identificador: |
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200016
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| Editor: |
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
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| Relação: |
10.1590/S1984-82502011000200016
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| Formato: |
text/html
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| Fonte: |
Brazilian Journal of Pharmaceutical Sciences v.47 n.2 2011
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| Direitos: |
info:eu-repo/semantics/openAccess
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