Autor(es):
Aquino, G. D A ; Stopilha, R. T. ; Pedrosa, M. F F ; Santos, K. S C R ; Egito, E. S T ; Oliveira, Anselmo Gomes de [UNESP] ; Silva-Junior, A. A.
Data: 2014
Identificador Persistente: http://hdl.handle.net/11449/72500
Origem: Oasisbr
Assunto(s): Beta-cyclodextrin; Ternary complexes; Triamcinolone; UV- Vis spectrophotometry; Validation; beta cyclodextrin; ternary complex factor; triamcinolone; triethanolamine; accuracy; analytic method; pH; photochemistry; quantitative analysis; room temperature; ultraviolet spectrophotometry; validation study
Descrição
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Triamcinolone (TRI), a drug widely used in the treatment of ocular inflammatory diseases, is practically insoluble in water, which limits its use in eye drops. Cyclodextrins (CDs) have been used to increase the solubility or dissolution rate of drugs. The purpose of the present study was to validate a UV-Vis spectrophotometric method for quantitative analysis of TRI in inclusion complexes with beta-cyclodextrin (B-CD) associated with triethanolamine (TEA) (ternary complex). The proposed analytical method was validated with respect to the parameters established by the Brazilian regulatory National Agency of Sanitary Monitoring (ANVISA). The analytical measurements of absorbance were made at 242nm, at room temperature, in a 1-cm path-length cuvette. The precision and accuracy studies were performed at five concentration levels (4, 8, 12, 18 and 20μg.mL -1). The B-CD associated with TEA did not provoke any alteration in the photochemical behavior of TRI. The results for the measured analytical parameters showed the success of the method. The standard curve was linear (r2 > 0.999) in the concentration range from 2 to 24 μg.mL -1. The method achieved good precision levels in the inter-day (relative standard deviation-RSD <3.4%) and reproducibility (RSD <3.8%) tests. The accuracy was about 80% and the pH changes introduced in the robustness study did not reveal any relevant interference at any of the studied concentrations. The experimental results demonstrate a simple, rapid and affordable UV-Vis spectrophotometric method that could be applied to the quantitation of TRI in this ternary complex.
Laboratório de Tecnologia e Biotecnologia Farmacêutica TecBioFar Departamento de Farmácia UFRN, Av. Cel. Gustavo Cordeiro de Farias, SN, Natal, RN, CEP 59180-010
Ciências Farmacêuticas UFRN, Natal, RN
Ciências Farmacêuticas Faculdade de Ciências Farmacêuticas Universidade Estadual Paulista-Unesp, Araraquara, SP
Ciências Farmacêuticas Faculdade de Ciências Farmacêuticas Universidade Estadual Paulista-Unesp, Araraquara, SP
