Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica
Ano de defesa: | 2023 |
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Autor(a) principal: | |
Orientador(a): | |
Banca de defesa: | , , , |
Tipo de documento: | Tese |
Tipo de acesso: | Acesso aberto |
Idioma: | por |
Instituição de defesa: |
Universidade Federal de Santa Maria
Centro de Ciências da Saúde |
Programa de Pós-Graduação: |
Programa de Pós-Graduação em Ciências Farmacêuticas
|
Departamento: |
Análises Clínicas e Toxicológicas
|
País: |
Brasil
|
Palavras-chave em Português: | |
Palavras-chave em Inglês: | |
Área do conhecimento CNPq: | |
Link de acesso: | http://repositorio.ufsm.br/handle/1/27897 |
Resumo: | Patients with chronic kidney disease (CKD) have the functions of filtering fluids and excreting impurities from the body compromised. Often, these patients have comorbidities, requiring the use of various medications and, sometimes, food for special purposes. In this study, highresolution continuous source atomic absorption spectrometry equipped with a graphite furnace (HR-CS GFAAS) is proposed as a method for the determination of Al, Cd, Cu, Mo and Pb in pharmaceutical products commonly used by patients with CKD. , since its accumulation in the body can cause damage to the health of patients. Analytical conditions such as pyrolysis and atomization temperatures, use of chemical modifiers and sample preparation were optimized. Atomic absorption spectrometry was used for elemental determinations in drug samples after acid digestion carried out in a microwave oven. Furthermore, extraction induced by emulsion breakage was used as a technique for preparing food samples for special purposes, allowing the transfer of the elements of interest from the oily matrix to the aqueous extract. The validation parameters (linearity, analytical range, accuracy, precision, limit of quantification, limit of detection and specificity) are in line with what is stipulated by the American Pharmacopoeia. The concentrations of Cd, Cu and Mo were within the limits recommended by the Brazilian Pharmacopoeia in all drug samples (n = 63). However, seven drug samples showed higher amounts of Pb (concentrations ranging from 12% to 238% above the permitted limit) than the limits stipulated for this element. All samples analyzed showed relatively considerable concentrations of Al (concentrations ranging from 0.21 to 214.92 μg g-¹), in view of the health condition of patients with CKD. Additionally, a comparative study was carried out between reference, generic, similar and magisterial drugs containing captopril and losartan potassium. It was noticed that generic drugs, in general, had the highest concentrations of the elements selected for analysis. In addition, Cd concentrations in food samples for enteral nutrition intended for chronic kidney patients were below the limit allowed by Brazilian legislation (0.01 mg kg-¹). However, two samples presented Pb concentration (samples 4 and 5) above the allowed limit (0.01 mg kg-¹). Furthermore, all samples analyzed in this study showed relatively considerable amounts of Al (0.72–1.66 mg kg-¹). The methods proposed for quantitative determinations of the analytes of interest by HR-CS GFAAS after the different sample preparations used in this study proved to be simple, fast and efficient. Thus, medicines and food for special purposes can be sources of exposure to elemental impurities in chronic kidney patients. Thus, it can reduce the quality and survival of these individuals. |
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2023-02-27T13:17:58Z2023-02-27T13:17:58Z2023-02-02http://repositorio.ufsm.br/handle/1/27897Patients with chronic kidney disease (CKD) have the functions of filtering fluids and excreting impurities from the body compromised. Often, these patients have comorbidities, requiring the use of various medications and, sometimes, food for special purposes. In this study, highresolution continuous source atomic absorption spectrometry equipped with a graphite furnace (HR-CS GFAAS) is proposed as a method for the determination of Al, Cd, Cu, Mo and Pb in pharmaceutical products commonly used by patients with CKD. , since its accumulation in the body can cause damage to the health of patients. Analytical conditions such as pyrolysis and atomization temperatures, use of chemical modifiers and sample preparation were optimized. Atomic absorption spectrometry was used for elemental determinations in drug samples after acid digestion carried out in a microwave oven. Furthermore, extraction induced by emulsion breakage was used as a technique for preparing food samples for special purposes, allowing the transfer of the elements of interest from the oily matrix to the aqueous extract. The validation parameters (linearity, analytical range, accuracy, precision, limit of quantification, limit of detection and specificity) are in line with what is stipulated by the American Pharmacopoeia. The concentrations of Cd, Cu and Mo were within the limits recommended by the Brazilian Pharmacopoeia in all drug samples (n = 63). However, seven drug samples showed higher amounts of Pb (concentrations ranging from 12% to 238% above the permitted limit) than the limits stipulated for this element. All samples analyzed showed relatively considerable concentrations of Al (concentrations ranging from 0.21 to 214.92 μg g-¹), in view of the health condition of patients with CKD. Additionally, a comparative study was carried out between reference, generic, similar and magisterial drugs containing captopril and losartan potassium. It was noticed that generic drugs, in general, had the highest concentrations of the elements selected for analysis. In addition, Cd concentrations in food samples for enteral nutrition intended for chronic kidney patients were below the limit allowed by Brazilian legislation (0.01 mg kg-¹). However, two samples presented Pb concentration (samples 4 and 5) above the allowed limit (0.01 mg kg-¹). Furthermore, all samples analyzed in this study showed relatively considerable amounts of Al (0.72–1.66 mg kg-¹). The methods proposed for quantitative determinations of the analytes of interest by HR-CS GFAAS after the different sample preparations used in this study proved to be simple, fast and efficient. Thus, medicines and food for special purposes can be sources of exposure to elemental impurities in chronic kidney patients. Thus, it can reduce the quality and survival of these individuals.Pacientes com doença renal crônica (DRC) apresentam as funções de filtragem de líquidos e excreção de impurezas do organismo comprometidas. Frequentemente, esses pacientes apresentam comorbidades, sendo necessário o uso de diversos medicamentos e, algumas vezes também, alimentos para fins especiais. Neste estudo, a espectrometria de absorção atômica de alta resolução com fonte contínua equipado com forno de grafite (HR-CS GFAAS) é proposta como método para determinação de Al, Cd, Cu, Mo e Pb em produtos farmacêuticos comumente utilizados por pacientes com DRC, visto que seu acúmulo no organismo pode provocar danos à saúde dos pacientes. As condições analíticas como temperatura de pirólise e atomização, uso de modificadores químicos e preparo de amostra foram otimizadas. A espectrometria de absorção atômica foi empregada para determinações elementares nas amostras de medicamentos após a digestão ácida realizada em forno de micro-ondas. Além disso, a extração induzida por quebra de emulsão foi utilizada como técnica de preparo das amostras de alimentos para fins especiais, permitindo a transferência dos elementos de interesse da matriz oleosa para o extrato aquoso. Os parâmetros de validação (linearidade, faixa analítica, exatidão, precisão, limite de quantificação, limite de detecção e especificidade) estão alinhados com o que é estipulado pela Farmacopeia Americana. As concentrações de Cd, Cu e Mo estiveram dentro dos limites recomendados pela Farmacopeia Brasileira em todas as amostras de medicamentos (n = 63). Entretanto, sete amostras de medicamentos apresentaram quantidades de Pb superiores (concentrações variando de 12% a 238% acima do limite permitido) aos limites estipulados para este elemento. Todas as amostras analisadas apresentaram concentrações relativamente consideráveis de Al (concentrações variando de 0,21 a 214,92 μg g-¹), tendo em vista a condição de saúde dos pacientes com DRC. Adicionalmente, foi realizado estudo comparativo entre medicamentos referência, genérico, similar e magistral contendo captopril e losartana potássica. Os medicamentos genéricos, de modo geral, apresentaram as maiores concentrações dos elementos selecionados para análise. Além disso, as concentrações de Cd nas amostras de alimentos para nutrição enteral destinadas a pacientes renais crônicos estavam abaixo do limite permitido pela legislação brasileira (0,01 mg kg-¹). No entanto, duas amostras apresentaram concentração de Pb (amostras 4 e 5) acima do limite permitido (0,01 mg kg-¹). Ademais, todas as amostras analisadas neste estudo apresentaram quantidades relativamente consideráveis de Al (0,72–1,66 mg kg-¹). Os métodos propostos para as determinações quantitativas dos analitos de interesse por HR-CS GFAAS após os diferentes preparos de amostra empregados neste estudo demonstraram-se simples, rápidos e eficientes. Dessa forma, medicamentos e alimentos para fins especiais podem ser fontes de exposição a impurezas elementares em pacientes renais crônicos. Podendo assim, reduzir a qualidade e sobrevida desses indivíduos.Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPESporUniversidade Federal de Santa MariaCentro de Ciências da SaúdePrograma de Pós-Graduação em Ciências FarmacêuticasUFSMBrasilAnálises Clínicas e ToxicológicasAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessMedicamentosAlimentos para fins especiaisNutrição enteralContaminantes inorgânicosEspectrometria de absorção atômicaMedicinesFood for special purposesEnteral nutritionInorganic contaminantsAtomic absorption spectrometryCNPQ::CIENCIAS DA SAUDE::FARMACIADeterminação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônicaDetermination of elementary impurities by atomic absorption spectrometry in pharmaceutical products used by patients with chronic kidney diseaseinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisSilva, Carine Vianahttp://lattes.cnpq.br/2004872342535591Becker, Emilene MendesBrucker, NatáliaSouto, Ricardo BizogneKunz, Simone Noremberghttp://lattes.cnpq.br/3500875996583297Maziero, Maiara40030000000560060060060060060060088e93e45-5e33-4094-a525-3ae55aa2e39ebe9083a6-f5ab-482d-b5fc-85dc60c81c8550db0163-8cb4-4a21-ab37-eb2ef7d3052b7e1d71bf-4010-48ae-bd49-256dee844c6dcf76b7c6-598e-40f0-9a07-08760c74cbd3582e69f8-1578-4c5b-b12a-91e530739af5reponame:Manancial - Repositório Digital da UFSMinstname:Universidade Federal de Santa Maria (UFSM)instacron:UFSMORIGINALTES_PPGCF_2023_MAZIERO_MAIARA.pdfTES_PPGCF_2023_MAZIERO_MAIARA.pdfTese de Doutoradoapplication/pdf13101515http://repositorio.ufsm.br/bitstream/1/27897/1/TES_PPGCF_2023_MAZIERO_MAIARA.pdf945a6fea4793c1c069b8cc95bd5610d2MD51CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; 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dc.title.por.fl_str_mv |
Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica |
dc.title.alternative.eng.fl_str_mv |
Determination of elementary impurities by atomic absorption spectrometry in pharmaceutical products used by patients with chronic kidney disease |
title |
Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica |
spellingShingle |
Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica Maziero, Maiara Medicamentos Alimentos para fins especiais Nutrição enteral Contaminantes inorgânicos Espectrometria de absorção atômica Medicines Food for special purposes Enteral nutrition Inorganic contaminants Atomic absorption spectrometry CNPQ::CIENCIAS DA SAUDE::FARMACIA |
title_short |
Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica |
title_full |
Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica |
title_fullStr |
Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica |
title_full_unstemmed |
Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica |
title_sort |
Determinação de impurezas elementares por espectrometria de absorção atômica em produtos farmacêuticos utilizados por pacientes com doença renal crônica |
author |
Maziero, Maiara |
author_facet |
Maziero, Maiara |
author_role |
author |
dc.contributor.advisor1.fl_str_mv |
Silva, Carine Viana |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/2004872342535591 |
dc.contributor.referee1.fl_str_mv |
Becker, Emilene Mendes |
dc.contributor.referee2.fl_str_mv |
Brucker, Natália |
dc.contributor.referee3.fl_str_mv |
Souto, Ricardo Bizogne |
dc.contributor.referee4.fl_str_mv |
Kunz, Simone Noremberg |
dc.contributor.authorLattes.fl_str_mv |
http://lattes.cnpq.br/3500875996583297 |
dc.contributor.author.fl_str_mv |
Maziero, Maiara |
contributor_str_mv |
Silva, Carine Viana Becker, Emilene Mendes Brucker, Natália Souto, Ricardo Bizogne Kunz, Simone Noremberg |
dc.subject.por.fl_str_mv |
Medicamentos Alimentos para fins especiais Nutrição enteral Contaminantes inorgânicos Espectrometria de absorção atômica |
topic |
Medicamentos Alimentos para fins especiais Nutrição enteral Contaminantes inorgânicos Espectrometria de absorção atômica Medicines Food for special purposes Enteral nutrition Inorganic contaminants Atomic absorption spectrometry CNPQ::CIENCIAS DA SAUDE::FARMACIA |
dc.subject.eng.fl_str_mv |
Medicines Food for special purposes Enteral nutrition Inorganic contaminants Atomic absorption spectrometry |
dc.subject.cnpq.fl_str_mv |
CNPQ::CIENCIAS DA SAUDE::FARMACIA |
description |
Patients with chronic kidney disease (CKD) have the functions of filtering fluids and excreting impurities from the body compromised. Often, these patients have comorbidities, requiring the use of various medications and, sometimes, food for special purposes. In this study, highresolution continuous source atomic absorption spectrometry equipped with a graphite furnace (HR-CS GFAAS) is proposed as a method for the determination of Al, Cd, Cu, Mo and Pb in pharmaceutical products commonly used by patients with CKD. , since its accumulation in the body can cause damage to the health of patients. Analytical conditions such as pyrolysis and atomization temperatures, use of chemical modifiers and sample preparation were optimized. Atomic absorption spectrometry was used for elemental determinations in drug samples after acid digestion carried out in a microwave oven. Furthermore, extraction induced by emulsion breakage was used as a technique for preparing food samples for special purposes, allowing the transfer of the elements of interest from the oily matrix to the aqueous extract. The validation parameters (linearity, analytical range, accuracy, precision, limit of quantification, limit of detection and specificity) are in line with what is stipulated by the American Pharmacopoeia. The concentrations of Cd, Cu and Mo were within the limits recommended by the Brazilian Pharmacopoeia in all drug samples (n = 63). However, seven drug samples showed higher amounts of Pb (concentrations ranging from 12% to 238% above the permitted limit) than the limits stipulated for this element. All samples analyzed showed relatively considerable concentrations of Al (concentrations ranging from 0.21 to 214.92 μg g-¹), in view of the health condition of patients with CKD. Additionally, a comparative study was carried out between reference, generic, similar and magisterial drugs containing captopril and losartan potassium. It was noticed that generic drugs, in general, had the highest concentrations of the elements selected for analysis. In addition, Cd concentrations in food samples for enteral nutrition intended for chronic kidney patients were below the limit allowed by Brazilian legislation (0.01 mg kg-¹). However, two samples presented Pb concentration (samples 4 and 5) above the allowed limit (0.01 mg kg-¹). Furthermore, all samples analyzed in this study showed relatively considerable amounts of Al (0.72–1.66 mg kg-¹). The methods proposed for quantitative determinations of the analytes of interest by HR-CS GFAAS after the different sample preparations used in this study proved to be simple, fast and efficient. Thus, medicines and food for special purposes can be sources of exposure to elemental impurities in chronic kidney patients. Thus, it can reduce the quality and survival of these individuals. |
publishDate |
2023 |
dc.date.accessioned.fl_str_mv |
2023-02-27T13:17:58Z |
dc.date.available.fl_str_mv |
2023-02-27T13:17:58Z |
dc.date.issued.fl_str_mv |
2023-02-02 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/doctoralThesis |
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doctoralThesis |
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http://repositorio.ufsm.br/handle/1/27897 |
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http://repositorio.ufsm.br/handle/1/27897 |
dc.language.iso.fl_str_mv |
por |
language |
por |
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400300000005 |
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600 600 600 600 600 600 600 |
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Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ |
eu_rights_str_mv |
openAccess |
dc.publisher.none.fl_str_mv |
Universidade Federal de Santa Maria Centro de Ciências da Saúde |
dc.publisher.program.fl_str_mv |
Programa de Pós-Graduação em Ciências Farmacêuticas |
dc.publisher.initials.fl_str_mv |
UFSM |
dc.publisher.country.fl_str_mv |
Brasil |
dc.publisher.department.fl_str_mv |
Análises Clínicas e Toxicológicas |
publisher.none.fl_str_mv |
Universidade Federal de Santa Maria Centro de Ciências da Saúde |
dc.source.none.fl_str_mv |
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