Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril
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 I...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Universidade de São Paulo
2011-06-01
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200016 |
| _version_ | 1818392978751750144 |
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| author | Raquel Nogueira Wagner Wollinger Thaís Elias da Silva Leonardo Mesquita de Oliveira Eliane Cristina Pires do Rego Gabriela Fernandes Moreira Juliano Smanioto Barin Luciane Varini Laporta Márcia Foster Mesko Celso Figueiredo Bittencourt Janaína Marques Rodrigues Valnei Smarçaro da Cunha |
| author_facet | Raquel Nogueira Wagner Wollinger Thaís Elias da Silva Leonardo Mesquita de Oliveira Eliane Cristina Pires do Rego Gabriela Fernandes Moreira Juliano Smanioto Barin Luciane Varini Laporta Márcia Foster Mesko Celso Figueiredo Bittencourt Janaína Marques Rodrigues Valnei Smarçaro da Cunha |
| author_sort | Raquel Nogueira |
| collection | DOAJ |
| description | 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).<br>Este artigo descreve a validação de método de cromatografia líquida de alta eficiência em fase reversa (CLAE-RP) com detector de fotodiodos (DAD) para determinação de substâncias relacionadas (impurezas orgânicas de síntese e produtos de degradação) de captopril segundo Farmacopéia Brasileira IV ed. Este estudo teve como objetivo garantir que o método é capaz de quantificar com exatidão o teor de substâncias relacionadas, um requisito essencial para que o teor de captopril seja determinado por balanço de massa no primeiro material de referência certificado (MRC) de fármacos brasileiro, o qual foi desenvolvido pelo Inmetro. A instabilidade do captopril em solução é discutida em detalhes e o teor de captopril determinado por balanço de massa é comparado com aqueles obtidos por titulação e por calorimetria exploratória diferencial (DSC). |
| first_indexed | 2024-12-14T05:38:00Z |
| format | Article |
| id | doaj.art-f1979f67b7bc4247a4a4ba5404571ad1 |
| institution | Directory Open Access Journal |
| issn | 1984-8250 2175-9790 |
| language | English |
| last_indexed | 2024-12-14T05:38:00Z |
| publishDate | 2011-06-01 |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-f1979f67b7bc4247a4a4ba5404571ad12022-12-21T23:15:07ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences1984-82502175-97902011-06-0147235136210.1590/S1984-82502011000200016Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captoprilRaquel NogueiraWagner WollingerThaís Elias da SilvaLeonardo Mesquita de OliveiraEliane Cristina Pires do RegoGabriela Fernandes MoreiraJuliano Smanioto BarinLuciane Varini LaportaMárcia Foster MeskoCelso Figueiredo BittencourtJanaína Marques RodriguesValnei Smarçaro da CunhaThis 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).<br>Este artigo descreve a validação de método de cromatografia líquida de alta eficiência em fase reversa (CLAE-RP) com detector de fotodiodos (DAD) para determinação de substâncias relacionadas (impurezas orgânicas de síntese e produtos de degradação) de captopril segundo Farmacopéia Brasileira IV ed. Este estudo teve como objetivo garantir que o método é capaz de quantificar com exatidão o teor de substâncias relacionadas, um requisito essencial para que o teor de captopril seja determinado por balanço de massa no primeiro material de referência certificado (MRC) de fármacos brasileiro, o qual foi desenvolvido pelo Inmetro. A instabilidade do captopril em solução é discutida em detalhes e o teor de captopril determinado por balanço de massa é comparado com aqueles obtidos por titulação e por calorimetria exploratória diferencial (DSC).http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200016CaptoprilMedicamentosMedicamentosMedicamentosCromatografia líquida de alta eficiênciaMedicamentosCaptoprilCaptoprilMedicinesMedicinesMedicinesHigh performance liquid chromatographyMedicinesCaptopril |
| spellingShingle | Raquel Nogueira Wagner Wollinger Thaís Elias da Silva Leonardo Mesquita de Oliveira Eliane Cristina Pires do Rego Gabriela Fernandes Moreira Juliano Smanioto Barin Luciane Varini Laporta Márcia Foster Mesko Celso Figueiredo Bittencourt Janaína Marques Rodrigues Valnei Smarçaro da Cunha Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril Brazilian Journal of Pharmaceutical Sciences Captopril Medicamentos Medicamentos Medicamentos Cromatografia líquida de alta eficiência Medicamentos Captopril Captopril Medicines Medicines Medicines High performance liquid chromatography Medicines Captopril |
| title | Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril |
| title_full | Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril |
| title_fullStr | Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril |
| title_full_unstemmed | Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril |
| title_short | Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril |
| title_sort | validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril |
| topic | Captopril Medicamentos Medicamentos Medicamentos Cromatografia líquida de alta eficiência Medicamentos Captopril Captopril Medicines Medicines Medicines High performance liquid chromatography Medicines Captopril |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200016 |
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