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Journal of Analytical Methods in Chemistry
Volume 2018, Article ID 7370651, 7 pages
https://doi.org/10.1155/2018/7370651
Research Article

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

1Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, Ein Helwan, Cairo 11795, Egypt
2Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt, El-Shorouk City, Cairo 11837, Egypt
3The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, The British University in Egypt, El-Shorouk City, Cairo 11837, Egypt
4Pharmaceutical Chemistry Department, Faculty of Pharmacy, Helwan University, Ein Helwan, Cairo 11795, Egypt

Correspondence should be addressed to Bassam M. Ayoub; ge.ude.eub@buoya.massab

Received 5 July 2017; Accepted 3 December 2017; Published 30 January 2018

Academic Editor: Krishna K. Verma

Copyright © 2018 Shereen Mowaka et al. 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.

Abstract

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.