Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil

An isocratic RP-HPLC method was developed for the determination of Cefditoren pivoxil in pharmaceutical formulations using a C-18 column with water–acetonitrile (50:50, v/v) as mobile phase and flow rate 1.2 mL/min (UV detection at 218 nm). Linearity was observed in the concentration range 1.0–250 μ...

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Detalles Bibliográficos
Autores principales: Annapurna, M. Mathrusri, Goutam, S.V.S., Anusha, S., Srinivas, L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2012
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760946/
https://www.ncbi.nlm.nih.gov/pubmed/29403785
http://dx.doi.org/10.1016/j.jpha.2012.06.003
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author Annapurna, M. Mathrusri
Goutam, S.V.S.
Anusha, S.
Srinivas, L.
author_facet Annapurna, M. Mathrusri
Goutam, S.V.S.
Anusha, S.
Srinivas, L.
author_sort Annapurna, M. Mathrusri
collection PubMed
description An isocratic RP-HPLC method was developed for the determination of Cefditoren pivoxil in pharmaceutical formulations using a C-18 column with water–acetonitrile (50:50, v/v) as mobile phase and flow rate 1.2 mL/min (UV detection at 218 nm). Linearity was observed in the concentration range 1.0–250 μg/mL (R(2)=0.999) with regression equation y=24194x+10749. The forced degradation studies were performed by using HCl, NaOH, and H(2)O(2), and thermal and UV radiation. Cefditoren pivoxil is more sensitive towards oxidation and alkaline conditions and resistant towards acidic and photolytic degradations. The method was validated as per ICH guidelines.
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spelling pubmed-57609462018-02-05 Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil Annapurna, M. Mathrusri Goutam, S.V.S. Anusha, S. Srinivas, L. J Pharm Anal Article An isocratic RP-HPLC method was developed for the determination of Cefditoren pivoxil in pharmaceutical formulations using a C-18 column with water–acetonitrile (50:50, v/v) as mobile phase and flow rate 1.2 mL/min (UV detection at 218 nm). Linearity was observed in the concentration range 1.0–250 μg/mL (R(2)=0.999) with regression equation y=24194x+10749. The forced degradation studies were performed by using HCl, NaOH, and H(2)O(2), and thermal and UV radiation. Cefditoren pivoxil is more sensitive towards oxidation and alkaline conditions and resistant towards acidic and photolytic degradations. The method was validated as per ICH guidelines. Xi'an Jiaotong University 2012-12 2012-06-27 /pmc/articles/PMC5760946/ /pubmed/29403785 http://dx.doi.org/10.1016/j.jpha.2012.06.003 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
Annapurna, M. Mathrusri
Goutam, S.V.S.
Anusha, S.
Srinivas, L.
Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil
title Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil
title_full Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil
title_fullStr Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil
title_full_unstemmed Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil
title_short Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil
title_sort development and validation of the stability-indicating lc–uv method for the determination of cefditoren pivoxil
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760946/
https://www.ncbi.nlm.nih.gov/pubmed/29403785
http://dx.doi.org/10.1016/j.jpha.2012.06.003
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