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| 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 |
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| 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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| Bandeira,Raquel Duarte da Costa Cunha; Uekane,Thaís Matsue; Cunha,Carolina Passos da; Cunha,Valnei Smarçaro da; Rodrigues,Janaína Marques; Godoy,Ronoel Luiz de Oliveira; la Cruz,Marcus Henrique Campino de. |
| A method using Liquid Chromatography Tanden Mass Spectrometry (LC-MS/MS) with matrix-matched calibration curve was developed and validated for determining ochratoxin A (OTA) in green coffee. Linearity was found between 3.0 and 23.0 ng.g-1. Mean recoveries ranged between 90.45% and 108.81%; the relative standard deviation under repeatability and intermediate precision conditions ranged from 5.39% to 9.94% and from 2.20% to 14.34%, respectively. The limits of detection and quantification were 1.2 ng.g-1 and 3.0 ng.g-¹, respectively. The method developed was suitable and contributed to the field of mycotoxin analysis, and it will be used for future production of the Certified Reference Material (CRM) for OTA in coffee. |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Coffee; Mycotoxin; Validation; HPLC; MS/MS. |
| Ano: 2012 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0101-20612012000400021 |
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