Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Revista JRG de Estudos Acadêmicos |
Texto Completo: | http://revistajrg.com/index.php/jrg/article/view/803 |
Resumo: | The validation process of analytical methodologies in research laboratories is essential for obtaining approval from ANVISA (Brazilian Health Regulatory Agency) and, consequently, for the registration and commercialization of drugs, whether they are reference or generic. This involves conducting specific tests on Active Pharmaceutical Ingredients (APIs), which must meet the specifications in pharmacopoeias and/or recognized compendia or, if necessary, validated methods that have been performed and proven to be efficient. In this context, the work aims to validate an analytical methodology for quantifying Calcium and Sodium in the raw material Lithium Carbonate, using the ICP-OES technique with the evaluation of various parameters, including selectivity, linearity, limit of quantification, precision (repeatability and intermediate), accuracy, working range, and robustness. The goal is to ensure that the method meets the requirements of current legislation. To perform the analyses, the samples were prepared by dissolving them in a 5 mol L-1 hydrochloric acid solution. The results demonstrated that the analytical method is capable of identifying and quantifying the analytes of interest without spectral interferences, maintaining a direct relationship between concentration and analytical response, and exhibiting precision and accuracy under the specified experimental conditions. |
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Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated samplingDesenvolvimento e validação de metodologia analítica para quantificação de sódio e cálcio em carbonato de lítio empregando a técnica de ICP OES com amostragem automatizadaImpurezasQuantificaçãoValidação de método analíticoLithium CarbonateImpuritiesICP OESAnalytical Method ValidationThe validation process of analytical methodologies in research laboratories is essential for obtaining approval from ANVISA (Brazilian Health Regulatory Agency) and, consequently, for the registration and commercialization of drugs, whether they are reference or generic. This involves conducting specific tests on Active Pharmaceutical Ingredients (APIs), which must meet the specifications in pharmacopoeias and/or recognized compendia or, if necessary, validated methods that have been performed and proven to be efficient. In this context, the work aims to validate an analytical methodology for quantifying Calcium and Sodium in the raw material Lithium Carbonate, using the ICP-OES technique with the evaluation of various parameters, including selectivity, linearity, limit of quantification, precision (repeatability and intermediate), accuracy, working range, and robustness. The goal is to ensure that the method meets the requirements of current legislation. To perform the analyses, the samples were prepared by dissolving them in a 5 mol L-1 hydrochloric acid solution. The results demonstrated that the analytical method is capable of identifying and quantifying the analytes of interest without spectral interferences, maintaining a direct relationship between concentration and analytical response, and exhibiting precision and accuracy under the specified experimental conditions. O processo de validação de metodologias analíticas em laboratórios de pesquisa é essencial para obter a aprovação da ANVISA e, consequentemente, o registro e a comercialização de medicamentos, sejam eles de referência ou genéricos. Isso envolve a realização de testes específicos em Insumos Farmacêuticos Ativos (IFAs), que devem atender às especificações em farmacopeias e/ou compêndios reconhecidos ou, se necessário, métodos validados que sejam realizados e comprovados sua eficiência. Neste contexto, o trabalho visa validar uma metodologia analítica para quantificar Cálcio e Sódio na matéria prima Carbonato de Lítio, utilizando a técnica de ICP-OES com avaliação de diversos parâmetros, incluindo seletividade, linearidade, limite de quantificação, precisão (repetibilidade e intermediária), exatidão, faixa de trabalho e robustez. O objetivo é garantir que o método atenda aos requisitos da legislação em vigor. Para realizar as análises, as amostras foram preparadas dissolvendo-as em uma solução de ácido clorídrico 5 mol L-1. Os resultados demonstraram que o método analítico é capaz de identificar e quantificar os analitos de interesse sem interferências espectrais, mantendo uma relação direta entre a concentração e a resposta analítica, além de apresentar conclusões e exatidão sob as condições experimentais condicionais.Editora JRG2023-11-23info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionArtigo avaliado pelos Paresapplication/pdfhttp://revistajrg.com/index.php/jrg/article/view/80310.55892/jrg.v6i13.803ark:/57118/JRG.v6i13.803JRG Journal of Academic Studies; Vol. 6 No. 13 (2023): JRG Journal of Academic Studies; 1943-1956JRG Journal of Academic Studies ; Vol. 6 Núm. 13 (2023): Revista JRG de Estudos Acadêmicos; 1943-1956JRG Journal of Academic Studies; V. 6 N. 13 (2023): Revista JRG de Estudos Acadêmicos; 1943-1956Revista JRG de Estudos Acadêmicos ; v. 6 n. 13 (2023): Revista JRG de Estudos Acadêmicos; 1943-19562595-1661ark:/57118/jrg.v6i13reponame:Revista JRG de Estudos Acadêmicosinstname:Editora JRGinstacron:JRGporhttp://revistajrg.com/index.php/jrg/article/view/803/739https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessMatricardi, Cintia de Souza MariaAlmeida, Daiane deMuller, Cristiano CabralRicardo, Letycia Lopes2023-11-23T16:13:57Zoai:ojs2.revistajrg.com:article/803Revistahttp://revistajrg.com/index.php/jrgPRIhttp://revistajrg.com/index.php/jrg/oaiprofessorjonas@gmail.com||2595-16612595-1661opendoar:2023-11-23T16:13:57Revista JRG de Estudos Acadêmicos - Editora JRGfalse |
dc.title.none.fl_str_mv |
Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling Desenvolvimento e validação de metodologia analítica para quantificação de sódio e cálcio em carbonato de lítio empregando a técnica de ICP OES com amostragem automatizada |
title |
Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling |
spellingShingle |
Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling Matricardi, Cintia de Souza Maria Impurezas Quantificação Validação de método analítico Lithium Carbonate Impurities ICP OES Analytical Method Validation |
title_short |
Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling |
title_full |
Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling |
title_fullStr |
Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling |
title_full_unstemmed |
Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling |
title_sort |
Development and validation of analytical methodology for quantifying sodium and calcium in lithium carbonate using the ICP OES technique with automated sampling |
author |
Matricardi, Cintia de Souza Maria |
author_facet |
Matricardi, Cintia de Souza Maria Almeida, Daiane de Muller, Cristiano Cabral Ricardo, Letycia Lopes |
author_role |
author |
author2 |
Almeida, Daiane de Muller, Cristiano Cabral Ricardo, Letycia Lopes |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Matricardi, Cintia de Souza Maria Almeida, Daiane de Muller, Cristiano Cabral Ricardo, Letycia Lopes |
dc.subject.por.fl_str_mv |
Impurezas Quantificação Validação de método analítico Lithium Carbonate Impurities ICP OES Analytical Method Validation |
topic |
Impurezas Quantificação Validação de método analítico Lithium Carbonate Impurities ICP OES Analytical Method Validation |
description |
The validation process of analytical methodologies in research laboratories is essential for obtaining approval from ANVISA (Brazilian Health Regulatory Agency) and, consequently, for the registration and commercialization of drugs, whether they are reference or generic. This involves conducting specific tests on Active Pharmaceutical Ingredients (APIs), which must meet the specifications in pharmacopoeias and/or recognized compendia or, if necessary, validated methods that have been performed and proven to be efficient. In this context, the work aims to validate an analytical methodology for quantifying Calcium and Sodium in the raw material Lithium Carbonate, using the ICP-OES technique with the evaluation of various parameters, including selectivity, linearity, limit of quantification, precision (repeatability and intermediate), accuracy, working range, and robustness. The goal is to ensure that the method meets the requirements of current legislation. To perform the analyses, the samples were prepared by dissolving them in a 5 mol L-1 hydrochloric acid solution. The results demonstrated that the analytical method is capable of identifying and quantifying the analytes of interest without spectral interferences, maintaining a direct relationship between concentration and analytical response, and exhibiting precision and accuracy under the specified experimental conditions. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-11-23 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Artigo avaliado pelos Pares |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://revistajrg.com/index.php/jrg/article/view/803 10.55892/jrg.v6i13.803 ark:/57118/JRG.v6i13.803 |
url |
http://revistajrg.com/index.php/jrg/article/view/803 |
identifier_str_mv |
10.55892/jrg.v6i13.803 ark:/57118/JRG.v6i13.803 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
http://revistajrg.com/index.php/jrg/article/view/803/739 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Editora JRG |
publisher.none.fl_str_mv |
Editora JRG |
dc.source.none.fl_str_mv |
JRG Journal of Academic Studies; Vol. 6 No. 13 (2023): JRG Journal of Academic Studies; 1943-1956 JRG Journal of Academic Studies ; Vol. 6 Núm. 13 (2023): Revista JRG de Estudos Acadêmicos; 1943-1956 JRG Journal of Academic Studies; V. 6 N. 13 (2023): Revista JRG de Estudos Acadêmicos; 1943-1956 Revista JRG de Estudos Acadêmicos ; v. 6 n. 13 (2023): Revista JRG de Estudos Acadêmicos; 1943-1956 2595-1661 ark:/57118/jrg.v6i13 reponame:Revista JRG de Estudos Acadêmicos instname:Editora JRG instacron:JRG |
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Editora JRG |
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JRG |
institution |
JRG |
reponame_str |
Revista JRG de Estudos Acadêmicos |
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Revista JRG de Estudos Acadêmicos |
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Revista JRG de Estudos Acadêmicos - Editora JRG |
repository.mail.fl_str_mv |
professorjonas@gmail.com|| |
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