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).
Highlights
IntroductionS. Cunha rials, which are accompanied by a certificate declaring the value of a specified property (the active pharmaceutical ingredients (APIs) content in the scope of this paper) and the associated measurement uncertainty, in order to guarantee metrological traceability (ISO Guide 35:2006; JCGM, 2008)
The Brazilian National Institute of Metrology, Standardization and Industrial Quality (Inmetro) has recentlycertified reference materials (CRMs) are defined as stable and homogeneous mate-352 R
Cunha rials, which are accompanied by a certificate declaring the value of a specified property and the associated measurement uncertainty, in order to guarantee metrological traceability (ISO Guide 35:2006; JCGM, 2008)
Summary
S. Cunha rials, which are accompanied by a certificate declaring the value of a specified property (the API content in the scope of this paper) and the associated measurement uncertainty, in order to guarantee metrological traceability (ISO Guide 35:2006; JCGM, 2008). Cunha rials, which are accompanied by a certificate declaring the value of a specified property (the API content in the scope of this paper) and the associated measurement uncertainty, in order to guarantee metrological traceability (ISO Guide 35:2006; JCGM, 2008) This traceability, which is a requirement of the ISO 17025:2005 standard and corresponds to “an unbroken chain of comparisons to national or international standards, all having stated uncertainties” (Duewer et al, 2004), cannot be ensured through the use of “non-certified” reference materials ( called reference standards)
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