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http://hdl.handle.net/1843/52327| Tipo: | Artigo de Periódico |
| Título: | UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil |
| Autor(es): | Naialy Fernandes Araújo Reis Luiz Felipe Gomes da Silva Mateus Araújo Castro e Souza Sílvia Ligório Fialho Carolina Paula de Souza Moreira Marcus Vinicius de Oliveira Andrade Washington Xavier de Paula Maria Beatriz de Abreu Glória Gerson Antônio Pianetti Christian Fernandes |
| Resumo: | One of the highest incidences of illegal drug products is related to phosphodiesterase-5 inhibitors, used in treatment of erectile dysfunction, including those containing sildenafil citrate and tadalafil. In this context, comprehensive evaluation of the quality of genuine and illegal medicines was performed. A simple and rapid ultra-high performance liquid chromatography (UHPLC-UV) method to quantify sildenafil and tadalafil in the presence of six degradation products was developed and validated. Sildenafil and tadalafil were submitted to forced degradation. The separation was carried out on a Kinetex C18 (50 × 2.1 mm; 1.7 μm) column with mobile phase composed of acetonitrile and aqueous triethylamine solution. The calibration curves were linear in the range of 14–126 μg mL−1 for sildenafil citrate and 4–36 μg mL−1 for tadalafil and the method proved to be selective, precise, accurate and robust. Sildenafil degraded in oxidative media, whereas tadalafil degraded in acidic, alkaline and oxidative environment. The chemical structures and the mechanisms for the formation of the main degradation products were proposed by UHPLC coupled to tandem mass spectrometry. The UHPLC-UV method was applied in the pharmaceutical analysis of genuine and seized medicines. Some of them did not meet quality standards, mainly due to contents below specifications and the large variation on contents between units within a batch. |
| Assunto: | Farmácia Medicamentos Qualidade de medicamentos Cromatografia líquida |
| Idioma: | eng |
| País: | Brasil |
| Editor: | Universidade Federal de Minas Gerais |
| Sigla da Instituição: | UFMG |
| Departamento: | FAR - DEPARTAMENTO DE ALIMENTOS FAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOS |
| Tipo de Acesso: | Acesso Aberto |
| Identificador DOI: | https://doi.org/10.1093/chromsci/bmaa073 |
| URI: | http://hdl.handle.net/1843/52327 |
| Data do documento: | Jan-2021 |
| metadata.dc.url.externa: | https://academic.oup.com/chromsci/article/59/1/30/5940794 |
| metadata.dc.relation.ispartof: | Journal of Chromatographic Science |
| Aparece nas coleções: | Artigo de Periódico |
Arquivos associados a este item:
| Arquivo | Descrição | Tamanho | Formato | |
|---|---|---|---|---|
| UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil.pdf | 850.16 kB | Adobe PDF | Visualizar/Abrir |
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