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Master's Dissertation
DOI
https://doi.org/10.11606/D.9.2001.tde-16122021-175459
Document
Author
Full name
Ixis Ivette Taymes Hidalgo
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2001
Supervisor
Committee
Kedor, Erika Rosa Maria (President)
Matta, Vladi Olga Consigliere de
Orsine, Eliane Maria de Almeida
Title in Portuguese
Desenvolvimento de metodologia para a determinação de cetirizina em preparações farmacêuticas
Keywords in Portuguese
Medicamento : controle de qualidade
Abstract in Portuguese
A espectrofotometria ultravioleta direta e derivada foi utilizada para o doseamento do dicloridrato de cetirizina em preparações farmacêuticas. Após identificação do dicloridrato de cetirizina de acordo com a Farmacopéia Européia 3ª ed.(1996), foi obtida a curva de Ringbom a 231nm utilizando soluções de cetirizina em ácido clorídrico 0,1N. A curva de calibração foi construída utilizando concentrações entre 6,0 e 24,0µg/mL, calculando-se o coeficiente de correlação e o erro padrão da estimativa. Na espectrofotometria derivada construiu-se uma curva de calibração utilizando a derivada de primeira ordem dos espectros obtidos a 238,75nm e a 225nm das concentrações entre 5,0 e 25,0µg/mL de dicloridrato de cetirizina em HCI 0,1N. O método para quantificação do fármaco nos comprimidos foi zero pico e no xarope, o ponto de anulação dos parabenos a 225nm. Realizaram-se os respectivos testes de especificidade para observar a metodologia a ser empregada com cada amostra. Determinou-se o teor de dicloridrato de cetirizina nas amostras obtendo-se valores entre 108,81% e 96,00% para o método direto e 98,67% e 95,34% para o método derivado quando aplicados em comprimidos, para xaropes o teor obtido com a amostra simulada foi de 100, 73% utilizando o método derivado. A exatidão do método foi comprovada mediante o teste de recuperação, obtendo-se valores entre 98,53% e 101,67% utilizando o método direto e de 98,80% a 102,00% pelo método derivado para comprimidos. Para xaropes a recuperação esteve entre valores de 100,22 e 100,89% quando determinada na amostra simulada. Os métodos apresentaram boa linearidade (0,9999), precisão e exatidão dentro dos limites estabelecidos e podem ser aplicados em amostras comerciais quando estas estiverem dentro das condições estudadas.
Title in English
Desenvolvimento de metodologia para a determinação de cetirizina em preparações farmacêuticas
Keywords in English
Medicamento : controle de qualidade
Abstract in English
The direct and derivative spectrophotometry was used to dosage cetirizine dihydrochloride in pharmaceuticals preparations. The identification of cetirizine dihydrochloride was done according to the European Pharmacopoeia 3rd edition - 1996. The Ringbom curve was constructed at 231 nm using cetirizine solution in 0.1 N hydrochloride acid. The calibration curve was constructed between concentrations of 6.0 and 24.0µg/mL, and correlation coefficient and standard error were calculated. ln the derivative spectrophotometry the curve was constructed using first order derivative of the spectra obtained at 238.75nm and 225nm of the concentration between 5.0 and 25.0µg/mL of cetirizine dihydrochloride in 0.1N hydrochloride acid. The quantification method used for tablets was the zero-peack and for syrups zero- crossing of the parabens at 225nm. Each methodology was submitted to respective specificity test. The concentration of cetirizine dihydrochloride determined in the tablets were between 108.81 - 96.00% with direct method and between 98.67 - 95.34% with derivative method. In syrups determined concentration was 100.73 % using derivative method. The accuracy of the method proved with the recovery test between 98.53 - 101.67% for the direct method and with the derivative method was 98.80 - 102.00% in tablets. For syrup the recovery was between 100.22 - 100.89% in the simulate sample. The methods have good linearity (r=0,9999), precision and accuracy at determined conditions. The proposed methods can be used for quantitative analisis of cetirizine dihydrochloride in comercial samples, at studied conditions.
 
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Publishing Date
2021-12-16
 
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