Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets:Dissolution and release kinetics  

作　　者：Maximiliano S.Sangoi Vítor Todeschini Martin Steppe 

机构地区：[1]Faculty of Pharmacy,Federal University of Rio de Janeiro [2]Faculty of Pharmacy,Federal University of Rio Grande do Sul

出　　处：《Journal of Pharmaceutical Analysis》2015年第2期137-141,共5页药物分析学报（英文版）

基　　金：CAPES(Coordenacao de Aperfeicoamento de Pessoal de Nível Superior);FAPERJ(Fundacao de Amparo a Pesquisa do Estado do Rio de Janeiro)for the financial support

摘　　要：A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic（LC） method equipped with a C18 monolithic column was developed and validated. LC system was operated isocratically at controlled temperature（40 1C） using a mobile phase of acetonitrile：methanol：0.03 M ammonium acetate（p H 3.8）（30：15：55, v/v/v）, run at a flow rate of 1.5 m L/min and detected at 208 nm. The best dissolution conditions for this formulation were achieved using a USP apparatus 2（paddle） at 100 rpm and 900 m L of phosphate buffer at p H 6.8 as the dissolution medium.Validation parameters such as the specificity, linearity, accuracy, precision, and robustness were evaluated according to international guidelines, giving results within the acceptable range. The kinetic parameters of drug release were also investigated using model-dependent methods and the dissolution profiles were best described by the Higuchi model. The validated dissolution test can be applied for quality control of this formulation.A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic（LC） method equipped with a C18 monolithic column was developed and validated. LC system was operated isocratically at controlled temperature（40 1C） using a mobile phase of acetonitrile：methanol：0.03 M ammonium acetate（p H 3.8）（30：15：55, v/v/v）, run at a flow rate of 1.5 m L/min and detected at 208 nm. The best dissolution conditions for this formulation were achieved using a USP apparatus 2（paddle） at 100 rpm and 900 m L of phosphate buffer at p H 6.8 as the dissolution medium.Validation parameters such as the specificity, linearity, accuracy, precision, and robustness were evaluated according to international guidelines, giving results within the acceptable range. The kinetic parameters of drug release were also investigated using model-dependent methods and the dissolution profiles were best described by the Higuchi model. The validated dissolution test can be applied for quality control of this formulation.

关 键 词：FESOTERODINE Dissolution test Low dose extendedrelease tablets Monolithic LC Release kinetics 

分 类 号：R912[医药卫生—药学]