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Determinação de captopril por HPLC acoplado a espectômetro de massa: aplicação em estudo de bioequivalência Soares, Aline Kércia Alves; de Moraes, Manoel Odorico; Bezerra, Fernando Antônio Frota; de Nucci, Gilberto & de Moraes, Maria Elisabete Amaral Resumo Objetivo: Avaliar a bioequivalencia de tres diferentes formulacoes de captopril 25mg (Capoten® como formulacao de referencia e Captopril produzido pela FURP e Farmanguinhos como formulacoes testes) em 24 voluntarios saudaveis de ambos os sexos. Metodos: Os voluntarios selecionados eram livres de doencas, como confirmado pelo exame fisico, psiquiatrico, ECG e exames laboratoriais. O estudo foi do tipo aberto, cruzado, em tres periodos com 5 dias de intervalo entre eles. As amostras plasmaticas foram obtidas num intervalo de 24 horas e as concentracoes de Captopril foram determinadas por cromatografia liquida de fase reversa acoplada a espectrometria de massa (LC-MS-MS). Resultados: A media geometrica para Capoten®/Captopril-FURP 25mg foi 96.9% para AUC0-24, 95.58 % para AUC0-∞, e 98.17% for Cmax. O intervalo de confianca (IC) de 90% foi de 84.8-100.65%, 88.5-109.42% e 82.52-116.8%, respectivamente. A media geometrica para Capoten®/ Captopril-Farmanguinhos 25mg foi 99.63 % para AUClast, 98.52% para AUC0-∞, e 95.52 para Cmax. O IC de 90% foi de 87.23-113.8%, 86.06-112.79% e 80.29-113.64%, respectivamente. Portanto, os IC de 90% para Cmax, AUClast, AUC0-∞ estavam dentro da variacao de 80-125% proposta pelo Food and Drug Administration. Conclusao: Os comprimidos de 25mg Captopril-FURP e Captopril-Farmanguinhos foram bioequivalentes ao Capoten® 25mg em sua taxa e extensao de absorcao. Palavras-chave Equivalência Terapêutica; Captopril; Cromatografia Líquida de Alta Pressão; Farmacocinética

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DETERMINATION OF CAPTOPRIL BY HPLCTANDEM MASS SPECTROMETRY: APPLICATION IN A BIOEQUIVALENCE STUDY Soares, Aline Kércia Alves; de Moraes, Manoel Odorico; Bezerra, Fernando Antônio Frota; de Nucci, Gilberto & de Moraes, Maria Elisabete Amaral Abstract Objective: To assess three different captopril tablet formulations of 25mg for their bioavailability (Capoten® as the reference formulation and Captopril from FURP and Farmanguinhos as the test formulations) in 24 healthy volunteers of both sexes. Methods: The volunteers were free from serious disease, as assessed by physical and psychiatric examination, EKG, and laboratory tests. The study was open, with a three-period crossover design and a five-day washout period. Plasma samples were obtained over a 24-hour interval. Captopril concentrations were determined by reversed phase liquid chromatography tandem mass spectrometry (LC-MS-MS). Results: The geometric mean for Capoten® /Captopril- FURP 25 mg was 96.9 % for AUC0-24, 95.58 % for AUC0-∞, and 98.17% for Cmax. The 90% confidence intervals (CI) were 84.8-100.65%, 88.5-109.42% and 82.52-116.8%, respectively. The geometric mean for Capoten®/Captopril-Farmanguinhos 25 mg was 99.63 % for AUClast, 98.52% for AUC0-∞, and 95.52 for Cmax. The 90% CI were 87.23-113.8%, 86.06-112.79% and 80.29-113.64%, respectively. Therefore, the 90% CI for Cmax, AUClast, AUC0-∞ were within the 80-125% interval proposed by the Food and Drug Administration. Conclusion: Captopril- FURP and Captopril-Farmanguinhos 25 mg tablets were bioequivalent to Capoten® 25 mg, according to both the rate and extent of absorption. Keywords Therapeutic Equivalency; Captopril; Chromatography; High Pressure Liquid; Pharmacokinetics

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