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Development studies of captopril certified reference material BJPS
Nogueira,Raquel; Rego,Eliane Cristina Pires do; Sousa,Marcus Vinicius Barreto; Wollinger,Wagner; Silva,Thaís Elias da; Moreira,Gabriela Fernandes; Barin,Juliano Smanioto; Laporta,Luciane Varini; Mesko,Márcia Foster; Bittencourt,Celso Figueiredo; Rodrigues,Janaína Marques; Cunha,Valnei Smarçaro da.
This paper describes the studies performed with the candidate Certified Reference Material (CRM) of captopril, the first CRM of an active pharmaceutical ingredient (API) in Brazil, including determination of impurities (organic, inorganic and volatiles), homogeneity testing, short- and long-term stability studies, calculation of captopril content using the mass balance approach, and estimation of the associated measurement uncertainty.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Captopril/qualitative analysis; Medicines/Certified Reference Standards; Medicines/analytical quality control; High Pressure Liquid Chromatography (HPLC)/qualitative analysis; Medicines/contamination.
Ano: 2011 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200015
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Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril BJPS
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.
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...
Tipo: Info:eu-repo/semantics/article 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.
Ano: 2011 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200016
Registros recuperados: 2
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