Title

Different spectrophotometric methods for simultaneous determination of trelagliptin and its acid degradation product

Document Type

Article

Publication Date

1-1-2018

Abstract

Copyright © 2018 Shereen Mowaka et al.-is is an open access article distributed under the Creative Commons Attribution License. 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 con;rm dealing with one major acid degradation product.-e proposed methods were developed by manipulating zero-order, ;rst-derivative, and ratio spectra of TRG and TAD using simultaneous equation, ;rst-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-257.2nm 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 oneway 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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