Development of hybrid spectrofluorimetric method for simultaneous determination of Valsartan and Sacubitril in LCZ696 tablets.

Autor: Youssef RM; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt. Electronic address: rasha.youssef@alexu.edu.eg., El-Nahass SA; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Pharos University in Alexandria, Alexandria, Egypt., Soliman SA; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Pharos University in Alexandria, Alexandria, Egypt., Younis SE; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Pharos University in Alexandria, Alexandria, Egypt.
Jazyk: angličtina
Zdroj: Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy [Spectrochim Acta A Mol Biomol Spectrosc] 2021 Jul 15; Vol. 256, pp. 119748. Date of Electronic Publication: 2021 Mar 26.
DOI: 10.1016/j.saa.2021.119748
Abstrakt: A hybrid Spectrofluorimetric method was developed for the simultaneous determination of binary mixtures, without prior separation steps. It coupled synchronous spectrofluorimetry with derivative ratio mathematical treatment. The method was applied successfully to quantify a new model binary mixture consisting of Valsartan (VAL) and Sacubitril (SAC). This mixture was recently approved by FDA as LCZ696. It added a great value in reducing morbidity and mortality in resistant heart failure (HF) patients. First derivative ratio synchronous fluorescence was measured at 258-295 (peak-to-peak) and 204 nm for VAL and SAC, respectively. ICH guidelines were fulfilled for the method validation. VAL and SAC showed linear responses in the range of 60-200 and 20-200 ng mL -1 , respectively. The proposed method was compared, in details, with the reported ones. Its high accuracy, selectivity, simplicity and affordable cost recommend method application in large-scale routine analysis of LCZ696 tablets. Moreover, reliable application of this new integrated spectrofluorimetric method suggests expansion of its application for various therapeutic combinations and different matrices.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2021 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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