Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method

Pramipexole belongs to a class of nonergot dopamine agonist recently approved for the treatment of early and advanced Parkinson's disease. A validated specific stability indicating reversed-phase liquid chromatographic method has been developed for the quantitative determination of pramipexole...

Descripción completa

Detalles Bibliográficos
Autores principales: Pawar, Shubhangi M., Khatal, Laxman D., Gabhe, Satish Y., Dhaneshwar, Sunil R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2013
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760940/
https://www.ncbi.nlm.nih.gov/pubmed/29403804
http://dx.doi.org/10.1016/j.jpha.2012.07.011
_version_ 1783291470282752000
author Pawar, Shubhangi M.
Khatal, Laxman D.
Gabhe, Satish Y.
Dhaneshwar, Sunil R.
author_facet Pawar, Shubhangi M.
Khatal, Laxman D.
Gabhe, Satish Y.
Dhaneshwar, Sunil R.
author_sort Pawar, Shubhangi M.
collection PubMed
description Pramipexole belongs to a class of nonergot dopamine agonist recently approved for the treatment of early and advanced Parkinson's disease. A validated specific stability indicating reversed-phase liquid chromatographic method has been developed for the quantitative determination of pramipexole in bulk as well as in pharmaceutical dosage forms in the presence of degradation products. Forced degradation studies were performed by exposition of drug to hydrolytic (acidic and basic), oxidative and photolytic stress conditions, as defined under ICH guideline Q1A (R2). Significant degradation was observed under hydrolytic, oxidative and photolytic conditions and the degradation products formed were identified by LC–MS.
format Online
Article
Text
id pubmed-5760940
institution National Center for Biotechnology Information
language English
publishDate 2013
publisher Xi'an Jiaotong University
record_format MEDLINE/PubMed
spelling pubmed-57609402018-02-05 Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method Pawar, Shubhangi M. Khatal, Laxman D. Gabhe, Satish Y. Dhaneshwar, Sunil R. J Pharm Anal Article Pramipexole belongs to a class of nonergot dopamine agonist recently approved for the treatment of early and advanced Parkinson's disease. A validated specific stability indicating reversed-phase liquid chromatographic method has been developed for the quantitative determination of pramipexole in bulk as well as in pharmaceutical dosage forms in the presence of degradation products. Forced degradation studies were performed by exposition of drug to hydrolytic (acidic and basic), oxidative and photolytic stress conditions, as defined under ICH guideline Q1A (R2). Significant degradation was observed under hydrolytic, oxidative and photolytic conditions and the degradation products formed were identified by LC–MS. Xi'an Jiaotong University 2013-04 2012-08-17 /pmc/articles/PMC5760940/ /pubmed/29403804 http://dx.doi.org/10.1016/j.jpha.2012.07.011 Text en © 2012 Xi'an Jiaotong University http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
spellingShingle Article
Pawar, Shubhangi M.
Khatal, Laxman D.
Gabhe, Satish Y.
Dhaneshwar, Sunil R.
Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method
title Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method
title_full Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method
title_fullStr Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method
title_full_unstemmed Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method
title_short Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method
title_sort establishment of inherent stability of pramipexole and development of validated stability indicating lc–uv and lc–ms method
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760940/
https://www.ncbi.nlm.nih.gov/pubmed/29403804
http://dx.doi.org/10.1016/j.jpha.2012.07.011
work_keys_str_mv AT pawarshubhangim establishmentofinherentstabilityofpramipexoleanddevelopmentofvalidatedstabilityindicatinglcuvandlcmsmethod
AT khatallaxmand establishmentofinherentstabilityofpramipexoleanddevelopmentofvalidatedstabilityindicatinglcuvandlcmsmethod
AT gabhesatishy establishmentofinherentstabilityofpramipexoleanddevelopmentofvalidatedstabilityindicatinglcuvandlcmsmethod
AT dhaneshwarsunilr establishmentofinherentstabilityofpramipexoleanddevelopmentofvalidatedstabilityindicatinglcuvandlcmsmethod

Ejemplares similares