Tadalafil and Sildenafil illicit association: Stability- indicating HPLC method, photodegradation kinetic and toxicological studies



Título del documento: Tadalafil and Sildenafil illicit association: Stability- indicating HPLC method, photodegradation kinetic and toxicological studies
Revue: Brazilian Journal of Pharmaceutical Sciences
Base de datos: PERIÓDICA
Número de sistema: 000451972
ISSN: 1984-8250
Autores: 2
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2
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Instituciones: 1Universidade Federal do Pampa, Faculdade de Farmacia, Uruguaiana, Rio Grande do Sul. Brasil
2Universidade Federal do Pampa, Programa de Pos-Graduacao em Ciencias Farmaceuticas, Uruguaiana, Rio Grande do Sul. Brasil
Año:
Volumen: 58
País: Brasil
Idioma: Inglés
Tipo de documento: Artículo
Enfoque: Analítico, descriptivo
Resumen en inglés The illicit market of counterfeit medicines containing sildenafil and tadalafil has been causing serious public health problems. Thus, further studies on this illicit association are needed. A stability-indicating HPLC method was developed for simultaneous determination of tadalafil (TAD) and sildenafil (SIL) using a C18 column (250 x 4.6 mm, 5 µm). Detection was achieved at 284 nm, for TAD, and 292 nm, for SIL. The method was considered to be specific, linear, precise, accurate, robust, and sensitive. In the photodegradation kinetic studies, the drugs showed a first-order reaction rate when isolated, and zero-order when associated. Toxicological assays demonstrated that the photodegraded drugs decreased cell viability in compared to non- degraded drugs, suggesting cytotoxic activity. Additional, mutagenic activity was not observed under the tested conditions. Photodegraded drugs, in association, depicted DNA damage index, suggesting genotoxic effects. The obtained results will be able to support the forensic intelligence laboratories, as well as to alert the population about the risk inherent to consuming counterfeit products
Disciplinas: Medicina
Palabras clave: Salud pública,
Farmacología,
Mercado ilegal,
Falsificación,
Tadalafil,
Sildenafil,
Fotodegradación,
Estabilidad química,
Toxicidad
Keyword: Public health,
Pharmacology,
Illicit market,
Counterfeiting,
Tadalafil,
Sildenafil,
Photodegradation,
Chemical stability,
Toxicity
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