Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril

Authors

  • Raquel Nogueira Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Wagner Wollinger Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Thaís Elias da Silva Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Leonardo Mesquita de Oliveira Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Eliane Cristina Pires do Rego Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Gabriela Fernandes Moreira Brazilian National Institute of Metrology, Standardization and Industrial Quality; Materials Metrology Division
  • Juliano Smanioto Barin Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Luciane Varini Laporta Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Márcia Foster Mesko Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Celso Figueiredo Bittencourt Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Janaína Marques Rodrigues Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory
  • Valnei Smarçaro da Cunha Brazilian National Institute of Metrology, Standardization and Industrial Quality; Chemical Metrology Division; Organic Analysis Laboratory

DOI:

https://doi.org/10.1590/S1984-82502011000200016

Keywords:

Captopril^i1^squalitative analy, Medicines^i1^sanaly, Medicines^i1^smethod validat, Medicines^i1^sanalytical quality cont, High performance liquid chromatography^i1^squalitative analy, Medicines^i1^scontaminat, Captopril^i1^scertified reference standa

Abstract

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).

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Published

2011-06-01

Issue

Vol. 47 No. 2 (2011)

Section

Articles

License

All content of the journal, except where identified, is licensed under a Creative Commons attribution-type BY.

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How to Cite

Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril . (2011). Brazilian Journal of Pharmaceutical Sciences, 47(2), 351-362. https://doi.org/10.1590/S1984-82502011000200016