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

Abstract

Abstract A green, stability-indicating UV-spectrophotometric methods were designed and optimized for the quantitative determination of gliclazide (GLI), a second-generation sulfonylurea widely used in the management of type 2 diabetes mellitus (T2DM). The methods integrate first-derivative spectrophotometry (D 1 ) and Fourier Self-Deconvolution (FSD) to resolve the extensive spectral overlap between GLI and its alkaline degradation product (Gliclazide Impurity A) without prior separation. The assay demonstrated excellent linearity within 2.5–25 µg/mL for GLI and 2.5–15 µg/mL for its degradation product. LOD ranged from 0.31 to 0.43 µg/mL and LOQ from 0.94 to 1.31 µg/mL for both analytes. Using ethanol as a green, non-toxic solvent further enhanced the method’s environmental sustainability. Method validation, performed according to ICH Q2(R1) guidelines, confirmed its selectivity, reproducibility, robustness, and accuracy with mean recoveries of 99.48 ± 0.83 and 100.87 ± 1.52 for GLI in the D 1 and FSD methods, respectively. Comprehensive forced degradation studies under alkaline stress verified the procedure’s stability-indicating capability, enabling reliable quantification of GLI in the presence of its degradation products. The greenness evaluation using Analytical Eco-Scale, GAPI, AGREE, NEMI tools, EPPI tool, AGSA tool, and MOGAPI method collectively affirmed the method’s eco-friendly and sustainable nature. Furthermore, the analytical strategy was comprehensively assessed using multi-dimensional tools, including RAPI and AMRI for analytical performance and reliability, CaFRI for carbon-footprint reduction, CACI for analytical practicality, and the RGB 12 model for an integrated multi-colored analytical profile. In summary, the developed methods provide a highly efficient, environmentally friendly, and analytical alternative to conventional chromatographic techniques for the routine quality control and green pharmaceutical analysis of gliclazide in bulk and dosage forms.