Análise químico-farmacêutica e estudo de estabilidade e de dissolução de cápsulas de flucloxacilina sódica
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Data
2012-08-08
Autores
Fiorentino, Flávia Angélica Másquio [UNESP]
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Editor
Universidade Estadual Paulista (Unesp)
Resumo
A flucloxacilina (FLU) é uma isoxazolilpenicilina semissintética, classificada como penicilina resistente à penicilinase estafilocócica. É ativa contra bactérias Gram-positivas, mas não é ativa contra Staphylococcus aureus resistentes à meticilina. A FLU é indicada para tratamento de infecções respiratórias, das articulações, síndrome do choque tóxico, pele, tecidos moles, endocardite e osteomielite, podendo ser administrada por via oral, intramuscular e endovenosa. A literatura apresenta alguns métodos de análise para FLU em fluidos biológicos, seus metabólitos e formas farmacêuticas. Neste trabalho foram desenvolvidos e validados métodos para análise qualitativa e quantitativa de FLU sódica em cápsula, bem como estudos de estabilidade para este fármaco. Para análise qualitativa, foram realizados os métodos de análise térmica, cromatografia em camada delgada, espectrofotometria nas regiões do infravermelho (IV) e ultravioleta (UV) e cromatografia líquida de alta eficiência (CLAE), possibilitando a identificação da amostra. Para a quantificação do fármaco foram desenvolvidos e validados os métodos: (1) ensaios microbiológicos por métodos de difusão em ágar e turbidimétrico, utilizando o microorganismo Staphylococcus aureus ATCC 25923 e ATCC 25923 IAL 1606, com faixa linear de 1,5 a 6,0 μg/mL e 4,0 a 16,0 μg/mL, respectivamente; exatidão de 98,98 e 99,73% e potência de 94,32 e 96,25%, respectivamente; (2) método espectrofotométrico na região do UV a 274 nm, utilizando água como solvente, com faixa linear em concentração de 50 a 100 μg/mL, exatidão de 100,09% e teor de 106,59%; (3) CLAE indicativo de estabilidade em comprimento de onda de 225 nm, fase móvel composta por ácido fosfórico (0,025 M), pH 5,5 e metanol (40:60 v/v) e o tempo de retenção médio foi de 4,5 minutos; a faixa linear foi de...
Flucloxacillin (FLU) is a semi-synthetic isoxazolilpenicillin, classified as resistant penicillin to penicillinase staphylococal. It is active against Gram-positive, but not against methicillin resistant Staphylococcus aureus. FLU is indicated to treat respiratory infections, joints, toxic shock syndrome, skin, soft tissue, endocarditis and osteomyelitis and it can be administered by mouth, intramuscular and intravenous via. The literature describes some methods to analyse FLU in biologic fluids, its metabolites and pharmaceutical forms. In this work, methodologies were developed and validated to qualitative and quantitative analysis of FLU in capsules and also, stability studies were carried out. To qualitative analysis, thermal analysis, infrared, ultraviolet spectrophotometry, thin layer chromatography and high performance liquid chromatographic methods were studied, allowing the identification of sample. To drug quantification, the following methods were validated: (1) Microbiological assays by agar diffusion and turbidimetric methods, using Staphylococcus aureus ATCC 25923 and ATCC 25923 IAL 1606 organisms, with linear range from 1.5 to 6.0 μg/mL and 4.0 to 16.0 μg/mL, accuracy of 98.98 and 99.73% and potency of 94.32 and 96.25%, respectively; (2) ultraviolet spectrophotometric method at 274 nm, using water as solvent; with concentration linear range from 50 to 100 μg/mL, accuracy of 100.09% and quantitation of 106.59%; (3) HPLC stability-indicating, using detection wavelength at 225 nm, mobile phase consisted of fosforic acid (0.025 M) pH 5.5 methanol (40:60, v/v), with retention time of 4.5 minutes; linear range was from 20 to 80 μg/mL, with accuracy of 100.06% and quantitation of 94.07% were obtained; (4) capillary electrophoresis stability-indicating method at 210 nm, eletrolite consisted of borate buffer solution (50 mM) and... (Complete abstract click electronic access below)
Flucloxacillin (FLU) is a semi-synthetic isoxazolilpenicillin, classified as resistant penicillin to penicillinase staphylococal. It is active against Gram-positive, but not against methicillin resistant Staphylococcus aureus. FLU is indicated to treat respiratory infections, joints, toxic shock syndrome, skin, soft tissue, endocarditis and osteomyelitis and it can be administered by mouth, intramuscular and intravenous via. The literature describes some methods to analyse FLU in biologic fluids, its metabolites and pharmaceutical forms. In this work, methodologies were developed and validated to qualitative and quantitative analysis of FLU in capsules and also, stability studies were carried out. To qualitative analysis, thermal analysis, infrared, ultraviolet spectrophotometry, thin layer chromatography and high performance liquid chromatographic methods were studied, allowing the identification of sample. To drug quantification, the following methods were validated: (1) Microbiological assays by agar diffusion and turbidimetric methods, using Staphylococcus aureus ATCC 25923 and ATCC 25923 IAL 1606 organisms, with linear range from 1.5 to 6.0 μg/mL and 4.0 to 16.0 μg/mL, accuracy of 98.98 and 99.73% and potency of 94.32 and 96.25%, respectively; (2) ultraviolet spectrophotometric method at 274 nm, using water as solvent; with concentration linear range from 50 to 100 μg/mL, accuracy of 100.09% and quantitation of 106.59%; (3) HPLC stability-indicating, using detection wavelength at 225 nm, mobile phase consisted of fosforic acid (0.025 M) pH 5.5 methanol (40:60, v/v), with retention time of 4.5 minutes; linear range was from 20 to 80 μg/mL, with accuracy of 100.06% and quantitation of 94.07% were obtained; (4) capillary electrophoresis stability-indicating method at 210 nm, eletrolite consisted of borate buffer solution (50 mM) and... (Complete abstract click electronic access below)
Descrição
Palavras-chave
Penicilina, Química farmacêutica, Soluções farmaceuticas
Como citar
FIORENTINO, Flávia Angélica Másquio. Análise químico-farmacêutica e estudo de estabilidade e de dissolução de cápsulas de flucloxacilina sódica. 2012. 272 f. Tese (doutorado) - Universidade Estadual Paulista, Faculdade de Ciências Farmacêuticas, 2012.