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

Nogueira, Raquel Fernandes Pupo; Wollinger, Wagner; Silva, Thaís Elias da; Oliveira, L. M.; Rego, Eliane Cristina Pires do; Moreira, Gabriela F.; Barin, Juliano Smanioto; Laporta, Lorenzo; Mesko, Márcia F.; Bittencourt, Celso Figueiredo; Rodrigues, Janaína Marques; Cunha, Valnei Smarçaro da

doi:10.1590/s1984-82502011000200016

Cited by 7 publications

(1 citation statement)

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“…The biotransformation of CPT is predominantly produced at thiol group level: reversible disulfide bonds are formed with albumin and other proteins; other transformations in blood involve formation of disulfide dimer and mixed disulfides of CPT with L-cysteine and glutathione. Due to its pharmacological relevance, but also due to its frequent use in cardiovascular therapy, a significant number of methods for captopril determination from tablets or different biological samples, including chromatographic methods, are proposed [2][3][4][5][6][7]. The pharmaceutical impurities may have a significant influence on the effects of a drug or may cause unwanted side-effects, therefore all the possible impurities of an active pharmaceutical ingredient (API) with concentrations above certain value must be detected, identified and quantified [8,9].…”

Section: Introductionmentioning

confidence: 99%

"HPLC-UV method approach for the analysis and impurity profiling of Captopril "

Cârje¹,

Balint²,

Ion³

et al. 2019

Studia UBB Chemia

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The aim of the study was to propose an improved HPLC/UV method for captopril impurity profiling based on forced degradation studies. Material and methods: the HPLC-UV analyses were performed on a Luna C18 column at 50 0 C by using a mobile phase consisting of phosphoric acid 15 mM and acetonitrile at 210 nm. Results and discussions: an HPLC method with superior characteristics to one described in the European Pharmacopoeia for captopril impurities profiling was proposed. The main degradation product of captopril was captopril disulfide (Impurity A), the concentration of which increases in all the conditions of forced degradation, except thermal degradation. UV light has led to the highest number of unknown impurities, but the oxidative degradation presented the highest rate of degradation (>88%). A total of 15 unknown impurities have been observed with significant area (>0.50%), who were not initially present in the captopril sample. Conclusions: The proposed HPLC method can be successfully applied in pharmaceutical analysis laboratories as a stability indicating method of captopril, allowing the separation of official impurities A, B, C, D and E and those formed under forced degradation conditions.

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