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Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method
The present study aimed to assess the stability of clonidine hydrochloride oral liquids (20-μg/mL) prepared from two different generic tablets in Ora-Blend and stored in amber plastic bottles. Physical and chemical stabilities were evaluated over a period of 90 days at 25°C. Analytical challenges we...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8631633/ https://www.ncbi.nlm.nih.gov/pubmed/34847160 http://dx.doi.org/10.1371/journal.pone.0260279 |
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author | Coache, Daphné Friciu, Mihaela Roullin, V. Gaëlle Boulé, Marianne Forest, Jean-Marc Leclair, Grégoire |
author_facet | Coache, Daphné Friciu, Mihaela Roullin, V. Gaëlle Boulé, Marianne Forest, Jean-Marc Leclair, Grégoire |
author_sort | Coache, Daphné |
collection | PubMed |
description | The present study aimed to assess the stability of clonidine hydrochloride oral liquids (20-μg/mL) prepared from two different generic tablets in Ora-Blend and stored in amber plastic bottles. Physical and chemical stabilities were evaluated over a period of 90 days at 25°C. Analytical challenges were overcome with the development of a new extraction procedure based on solid phase extraction to ensure efficient clonidine hydrochloride quantification. The absence of physical instabilities, evaluated by qualitative and quantitative measurements (static multiple light scattering), as well as the absence of chemical instabilities, evidenced by a stability-indicating HPLC-UV method, confirmed that a beyond-use date of 90 days was appropriate for these compounded oral liquids. |
format | Online Article Text |
id | pubmed-8631633 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-86316332021-12-01 Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method Coache, Daphné Friciu, Mihaela Roullin, V. Gaëlle Boulé, Marianne Forest, Jean-Marc Leclair, Grégoire PLoS One Research Article The present study aimed to assess the stability of clonidine hydrochloride oral liquids (20-μg/mL) prepared from two different generic tablets in Ora-Blend and stored in amber plastic bottles. Physical and chemical stabilities were evaluated over a period of 90 days at 25°C. Analytical challenges were overcome with the development of a new extraction procedure based on solid phase extraction to ensure efficient clonidine hydrochloride quantification. The absence of physical instabilities, evaluated by qualitative and quantitative measurements (static multiple light scattering), as well as the absence of chemical instabilities, evidenced by a stability-indicating HPLC-UV method, confirmed that a beyond-use date of 90 days was appropriate for these compounded oral liquids. Public Library of Science 2021-11-30 /pmc/articles/PMC8631633/ /pubmed/34847160 http://dx.doi.org/10.1371/journal.pone.0260279 Text en © 2021 Coache et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Coache, Daphné Friciu, Mihaela Roullin, V. Gaëlle Boulé, Marianne Forest, Jean-Marc Leclair, Grégoire Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method |
title | Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method |
title_full | Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method |
title_fullStr | Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method |
title_full_unstemmed | Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method |
title_short | Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method |
title_sort | stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction hplc-uv method |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8631633/ https://www.ncbi.nlm.nih.gov/pubmed/34847160 http://dx.doi.org/10.1371/journal.pone.0260279 |
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