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August 24, 2026Scientific ReportsOpen Access

Sustainable stability-indicating spectra manipulations for the concurrent quantification of gliclazide and its impurity A as the possible alkaline degradation product: Multi-Color Analytical Profile Assessment

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Authors

EKEbraam B. KamelAAAhmed Elsayed AbdelmegeedHSHanaa Saleh

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Overview

Analytical method validation reveals precise concurrent quantification of gliclazide and its degradation product, highlighting a sustainable alternative for pharmaceutical quality control.

Key Points

  • To develop and validate sustainable, stability-indicating UV-spectrophotometric methods for the simultaneous quantification of gliclazide and its alkaline degradation product without prior physical separation.
  • Integrated first-derivative spectrophotometry (D1) and Fourier Self-Deconvolution (FSD) using ethanol as an eco-friendly solvent to resolve overlapping UV spectra.
  • Validated the assay according to ICH Q2(R1) guidelines under alkaline forced-degradation conditions and assessed environmental sustainability using multi-metric greenness tools (such as AGREE, GAPI, and the RGB 12 model).
  • Achieved linear detection ranges of 2.5–25 µg/mL for gliclazide and 2.5–15 µg/mL for its degradation product, with limits of detection spanning 0.31–0.43 µg/mL and limits of quantitation spanning 0.94–1.31 µg/mL.
  • Yielded mean recovery rates of 99.48 ± 0.83% for the D1 method and 100.87 ± 1.52% for the FSD method when measuring gliclazide.

Cite This Study

Kamel et al. (2026) studied this question.

synapsesocial.com/papers/6a8c0086bca056c88e6df490https://doi.org/10.1038/s41598-026-67045-4
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