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Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride
Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium (RZ)–mosapride citrate (MR) and RZ–itopride hydrochloride (IO) mixtures in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge C18 column using two mo...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Xi'an Jiaotong University
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761220/ https://www.ncbi.nlm.nih.gov/pubmed/29403889 http://dx.doi.org/10.1016/j.jpha.2013.09.009 |
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author | El-Fatatry, Hamed M. Mabrouk, Mokhtar M. Hewala, Ismail I. Emam, Ehab H. |
author_facet | El-Fatatry, Hamed M. Mabrouk, Mokhtar M. Hewala, Ismail I. Emam, Ehab H. |
author_sort | El-Fatatry, Hamed M. |
collection | PubMed |
description | Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium (RZ)–mosapride citrate (MR) and RZ–itopride hydrochloride (IO) mixtures in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge C18 column using two mobile phases: the first for RZ–MR mixture consisted of acetonitrile: 0.025 M KH(2)PO(4) solution: TEA (30:69:1 v/v; pH 7.0); the second for RZ–IO mixture was at ratio of 25:74:1 (v/v; pH 9.25). The detection wavelength was 283 nm. The two methods were validated and validation acceptance criteria were met in all cases. Peak purity testing using contrast angle theory, relative absorbance and log A versus the wavelengths plots were presented. The % recoveries of the intact drugs were between 99.1% and 102.2% with RSD% values less than 1.6%. Application of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations. |
format | Online Article Text |
id | pubmed-5761220 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Xi'an Jiaotong University |
record_format | MEDLINE/PubMed |
spelling | pubmed-57612202018-02-05 Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride El-Fatatry, Hamed M. Mabrouk, Mokhtar M. Hewala, Ismail I. Emam, Ehab H. J Pharm Anal Original Article Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium (RZ)–mosapride citrate (MR) and RZ–itopride hydrochloride (IO) mixtures in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge C18 column using two mobile phases: the first for RZ–MR mixture consisted of acetonitrile: 0.025 M KH(2)PO(4) solution: TEA (30:69:1 v/v; pH 7.0); the second for RZ–IO mixture was at ratio of 25:74:1 (v/v; pH 9.25). The detection wavelength was 283 nm. The two methods were validated and validation acceptance criteria were met in all cases. Peak purity testing using contrast angle theory, relative absorbance and log A versus the wavelengths plots were presented. The % recoveries of the intact drugs were between 99.1% and 102.2% with RSD% values less than 1.6%. Application of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations. Xi'an Jiaotong University 2014-08 2013-09-23 /pmc/articles/PMC5761220/ /pubmed/29403889 http://dx.doi.org/10.1016/j.jpha.2013.09.009 Text en © 2013 Xi’an Jiaotong University. Production and hosting by Elsevier B.V. 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 | Original Article El-Fatatry, Hamed M. Mabrouk, Mokhtar M. Hewala, Ismail I. Emam, Ehab H. Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride |
title | Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride |
title_full | Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride |
title_fullStr | Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride |
title_full_unstemmed | Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride |
title_short | Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride |
title_sort | stability-indicating hplc–dad methods for determination of two binary mixtures: rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761220/ https://www.ncbi.nlm.nih.gov/pubmed/29403889 http://dx.doi.org/10.1016/j.jpha.2013.09.009 |
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