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Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product

New spectrophotometric and chemometric methods were carried out for the simultaneous assay of trelagliptin (TRG) and its acid degradation product (TAD) and applied successfully as a stability indicating assay to recently approved Zafatek® tablets. TAD was monitored using TLC to ensure complete degra...

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Detalles Bibliográficos
Autores principales: Mowaka, Shereen, Ayoub, Bassam M., Hassan, Mostafa A., Zaghary, Wafaa A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831872/
https://www.ncbi.nlm.nih.gov/pubmed/29629213
http://dx.doi.org/10.1155/2018/7370651
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author Mowaka, Shereen
Ayoub, Bassam M.
Hassan, Mostafa A.
Zaghary, Wafaa A.
author_facet Mowaka, Shereen
Ayoub, Bassam M.
Hassan, Mostafa A.
Zaghary, Wafaa A.
author_sort Mowaka, Shereen
collection PubMed
description New spectrophotometric and chemometric methods were carried out for the simultaneous assay of trelagliptin (TRG) and its acid degradation product (TAD) and applied successfully as a stability indicating assay to recently approved Zafatek® tablets. TAD was monitored using TLC to ensure complete degradation. Furthermore, HPLC was used to confirm dealing with one major acid degradation product. The proposed methods were developed by manipulating zero-order, first-derivative, and ratio spectra of TRG and TAD using simultaneous equation, first-derivative, and mean-centering methods, respectively. Using Spectra Manager II and Minitab v.14 software, the absorbance at 274 nm–260.4 nm, amplitudes at 260.4 nm–274.0 nm, and mean-centered values at 287.6 nm–257.2 nm were measured against methanol as a blank for TRG and TAD, respectively. Linearity and the other validation parameters were acceptable at concentration ranges of 5–50 μg/mL and 2.5–25 μg/mL for TRG and TAD, respectively. Using one-way analysis of variance (ANOVA), the optimized methods were compared and proved to be accurate for the simultaneous assay of TRG and TAD.
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spelling pubmed-58318722018-04-08 Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product Mowaka, Shereen Ayoub, Bassam M. Hassan, Mostafa A. Zaghary, Wafaa A. J Anal Methods Chem Research Article New spectrophotometric and chemometric methods were carried out for the simultaneous assay of trelagliptin (TRG) and its acid degradation product (TAD) and applied successfully as a stability indicating assay to recently approved Zafatek® tablets. TAD was monitored using TLC to ensure complete degradation. Furthermore, HPLC was used to confirm dealing with one major acid degradation product. The proposed methods were developed by manipulating zero-order, first-derivative, and ratio spectra of TRG and TAD using simultaneous equation, first-derivative, and mean-centering methods, respectively. Using Spectra Manager II and Minitab v.14 software, the absorbance at 274 nm–260.4 nm, amplitudes at 260.4 nm–274.0 nm, and mean-centered values at 287.6 nm–257.2 nm were measured against methanol as a blank for TRG and TAD, respectively. Linearity and the other validation parameters were acceptable at concentration ranges of 5–50 μg/mL and 2.5–25 μg/mL for TRG and TAD, respectively. Using one-way analysis of variance (ANOVA), the optimized methods were compared and proved to be accurate for the simultaneous assay of TRG and TAD. Hindawi 2018-01-30 /pmc/articles/PMC5831872/ /pubmed/29629213 http://dx.doi.org/10.1155/2018/7370651 Text en Copyright © 2018 Shereen Mowaka et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Mowaka, Shereen
Ayoub, Bassam M.
Hassan, Mostafa A.
Zaghary, Wafaa A.
Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product
title Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product
title_full Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product
title_fullStr Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product
title_full_unstemmed Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product
title_short Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product
title_sort different spectrophotometric methods for simultaneous determination of trelagliptin and its acid degradation product
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831872/
https://www.ncbi.nlm.nih.gov/pubmed/29629213
http://dx.doi.org/10.1155/2018/7370651
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