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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...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Xi'an Jiaotong University
2015
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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. |
format | Online Article Text |
id | pubmed-5761478 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Xi'an Jiaotong University |
record_format | MEDLINE/PubMed |
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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