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Novel eco-friendly spectrophotometric approaches for resolution of fixed dose formulation of phenylbutazone with minor component of dexamethasone: Greenness assessment by AGREE tool

[Display omitted] •Two novel methods (D2CNV and D2CV) are proposed for the determination of PBZ.•Three approaches were conducted to get each component alone in its zero or first derivative forms.•Results obtained from spectrum addition technique are compared to standard addition technique.•Using the...

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Published in:Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy Molecular and biomolecular spectroscopy, 2023-09, Vol.297, p.122707, Article 122707
Main Authors: Hagag, Mahmoud G., Hemdan, Ahmed M., Fahmy, Nesma M., Abbas, Samah S., Nadim, Ahmed H.
Format: Article
Language:English
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Summary:[Display omitted] •Two novel methods (D2CNV and D2CV) are proposed for the determination of PBZ.•Three approaches were conducted to get each component alone in its zero or first derivative forms.•Results obtained from spectrum addition technique are compared to standard addition technique.•Using the most recent greenness assessment tool (AGREE), the greenness profile of the proposed methods was assessed. Spectrophotometric resolution of severely overlapped binary mixtures with minor component is challenging. Herein, coupling of mathematical manipulation steps with sample enrichment was conducted on the binary mixture spectrum of Phenylbutazone (PBZ) and Dexamethasone sodium phosphate (DEX) to resolve, for the first time each component separately. Simultaneous determination of both components in a mixture ratio of 1:0.002 was achieved in their zero or first order spectra by the recent factorized response method along with ratio subtraction and constant multiplication methods; all coupled with spectrum subtraction. In addition, a novel second derivative concentration value and second derivative constant value methods were developed for PBZ determination. The concentration of the minor component DEX was obtained, without preliminary separation steps by derivative ratio after sample enrichment by either spectrum addition or standard addition. Spectrum addition approach showed superior characteristics compared to standard addition technique. All proposed methods were placed through a comparative study. Linear correlation was found to be 1.5–18.0 µg/mL for PBZ, and 4.0–45.0 µg/mL for DEX. The proposed methods were validated in accordance with ICH guidelines. The greenness assessment of the proposed spectrophotometric methods was evaluated by AGREE software. Results obtained from the statistical data were evaluated by comparing to one another as well as the official USP methods. These methods offer a cost and time effective platform to analyze bulk materials and combined veterinary formulation.
ISSN:1386-1425
DOI:10.1016/j.saa.2023.122707