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

A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic (LC) method equipped with a C(18) monolithic column was developed and validated. LC system was operated isocratically at controlled temperature (40 °C) using a mobile phase of acetonitrile:methanol:0.0...

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Autores principales: Sangoi, Maximiliano S., Todeschini, Vítor, Steppe, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761478/
https://www.ncbi.nlm.nih.gov/pubmed/29403925
http://dx.doi.org/10.1016/j.jpha.2014.10.001
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author Sangoi, Maximiliano S.
Todeschini, Vítor
Steppe, Martin
author_facet Sangoi, Maximiliano S.
Todeschini, Vítor
Steppe, Martin
author_sort Sangoi, Maximiliano S.
collection PubMed
description A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic (LC) method equipped with a C(18) monolithic column was developed and validated. LC system was operated isocratically at controlled temperature (40 °C) using a mobile phase of acetonitrile:methanol:0.03 M ammonium acetate (pH 3.8) (30:15:55, v/v/v), run at a flow rate of 1.5 mL/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 mL of phosphate buffer at pH 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.
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spelling pubmed-57614782018-02-05 Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets: Dissolution and release kinetics Sangoi, Maximiliano S. Todeschini, Vítor Steppe, Martin J Pharm Anal Short Communication A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic (LC) method equipped with a C(18) monolithic column was developed and validated. LC system was operated isocratically at controlled temperature (40 °C) using a mobile phase of acetonitrile:methanol:0.03 M ammonium acetate (pH 3.8) (30:15:55, v/v/v), run at a flow rate of 1.5 mL/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 mL of phosphate buffer at pH 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. Xi'an Jiaotong University 2015-04 2014-10-23 /pmc/articles/PMC5761478/ /pubmed/29403925 http://dx.doi.org/10.1016/j.jpha.2014.10.001 Text en © 2014 Xi’an Jiaotong University. Production and hosting by Elsevier B.V. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Short Communication
Sangoi, Maximiliano S.
Todeschini, Vítor
Steppe, Martin
Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets: Dissolution and release kinetics
title Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets: Dissolution and release kinetics
title_full Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets: Dissolution and release kinetics
title_fullStr Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets: Dissolution and release kinetics
title_full_unstemmed Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets: Dissolution and release kinetics
title_short Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets: Dissolution and release kinetics
title_sort monolithic lc method applied to fesoterodine fumarate low dose extended-release tablets: dissolution and release kinetics
topic Short Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761478/
https://www.ncbi.nlm.nih.gov/pubmed/29403925
http://dx.doi.org/10.1016/j.jpha.2014.10.001
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