article · BMC Chemistry
Quality control in pharmaceutical manufacturing increasingly demands sustainable, affordable, and rapid analytical procedures. This research develops a green spectrophotometric assay to measure two combined antimicrobial agents, Cefuroxime Axetil and Ornidazole, simultaneously in a single formulation without requiring prior physical separation. The procedure applies Q-absorbance isosbestic point methodology alongside first derivative photometric analysis across synthetic mixtures and laboratory-prepared tablets. Validated against International Council for Harmonisation guidelines, the methods achieved low limits of quantitation for both compounds. When compared to conventional high-performance liquid chromatography techniques, the approach demonstrated statistically equivalent accuracy while requiring simpler operations. Furthermore, environmental assessments using the Analytical Eco-Scale and AGREE metrics confirmed that this spectrophotometric protocol offers significantly higher greenness scores than existing chromatographic methods, offering an eco-friendly and straightforward alternative for medication analysis.
Pharmaceutical quality control often relies on complex, solvent-intensive chromatographic techniques to analyse combination medicines. Replacing these methods with simpler, greener spectrophotometric assays reduces toxic chemical waste, cuts laboratory testing costs, and speeds up the release of medicines, all while maintaining rigorous analytical accuracy and meeting international regulatory standards.
This work is an applied analytical protocol tested on laboratory-prepared tablets, placing it close to practical adoption in routine quality control environments. It could directly benefit pharmaceutical manufacturers, contract testing laboratories, and regulatory agencies seeking to reduce the operational costs and environmental footprint associated with conventional chromatography when testing fixed-dose antibiotic combinations.
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Sustainability, affordability and instant reproducible responses are urgently targeted for quality control of drug analyses. Synergistic antimicrobial combination of a cephalosporin and an antiprotozoal in a single pill, is much convenient and manoeuvrable. Earlier chromatographic attempts of mixture analysis are reported. Herein, the first green spectrophotometric assay of pharmaceutical formulation of two antibiotics is done simultaneously; Cefuroxime Axetil and Ornidazole. The fixed dose combination is determined without prior separation. Q-Absorbance Isosbestic point methodology, coupled with first derivative photometric analysis, are applied for drugs’ assay in synthetic binary mixtures of different concentration ratios. Validation in regard to international council for harmonization is confirmed prior to methods’ application to laboratory prepared tablets. Limits of quantitation reached down to 1.509 µg mL⁻¹ (CFUR-X at the isosbestic point), 2.094 µg mL⁻¹ (ORNI at the isosbestic point), and 2.364 µg mL⁻¹ (ORNI by first derivative). The proposed techniques, when compared statistically with the reported HPLC method, declared insignificant differences. As an environmental obligation, the proposed method’s greenness was compared to the reported HPLC and HPTLC procedures using Analytical Eco-Scale and AGREE metrics. The first spectrophotometric simultaneous assay of CFUR-X and ORNI via isosbestic as well as 1 D shows higher greenness scores preceding the previous chromatographic ones, which assures ecofriendly, simple and applicable analysis.
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DOI: 10.1186/s13065-026-01790-5
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