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<p>Design of experiments has emerged as an influential and proactive approach that demonstrated favored applicability in optimizing chromatographic procedures. Quality-by-design guarantees the long-standing efficiency of the developed HPLC method reducing the need for costly and resource-intensive univariate approach. A low environmental footprint, sensitive, fast, and simple HPLC method was developed for concurrent estimation of cefixime (CFX) and ornidazole (ORN) in their raw materials, laboratory-prepared tablets, and pharmaceutical formulations using 2<sup>3</sup> full factorial design. The separation was performed on a cyano column through UV detection at 300&#xa0;nm in less than 4&#xa0;min. The elution was achieved using a mobile phase (pH = 6.0) composed of methanol and 0.3% triethylamine in ratio of (85%: 15%, v/v), respectively with a flow rate of 1 mL/min. The method’s validity was established with ICH <InlineEquation ID="IEq1"> <EquationSource Format="TEX">\(\:{\text{Q}}_{2}{\text{R}}_{1}\)</EquationSource> </InlineEquation> regulations. Excellent linear correlation (<i>r</i> = 0.9999) was established within concentration ranges lies between 1 and 50&#xa0;µg/mL and 0.5–50&#xa0;µg/mL with high percent found of 100.04 ± 0.82 and 99.99 ± 1.01 for CFX and ORN, respectively. The approach exhibited high precision (% RDS &lt; 2) and sensitivity with detection limits of 0.07 and 0.09&#xa0;µg/mL and quantification limits of 0.21 and 0.28&#xa0;µg/mL for CFX and ORN, respectively. Several metrics evidenced the method’s greenness and sustainability profile.</p>

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Emerging quality-by-design optimized HPLC method for the concurrent determination of cefixime and ornidazole: a multi-criteria green and blue environmental footprinting

  • 期刊论文

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  • 发表日期：

    2026年5月26日

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  • Yasmeen E. Mostafa,
  • Fawzi Elsebaei,
  • Mohammed El-Sayed Metwally

摘要

Design of experiments has emerged as an influential and proactive approach that demonstrated favored applicability in optimizing chromatographic procedures. Quality-by-design guarantees the long-standing efficiency of the developed HPLC method reducing the need for costly and resource-intensive univariate approach. A low environmental footprint, sensitive, fast, and simple HPLC method was developed for concurrent estimation of cefixime (CFX) and ornidazole (ORN) in their raw materials, laboratory-prepared tablets, and pharmaceutical formulations using 23 full factorial design. The separation was performed on a cyano column through UV detection at 300 nm in less than 4 min. The elution was achieved using a mobile phase (pH = 6.0) composed of methanol and 0.3% triethylamine in ratio of (85%: 15%, v/v), respectively with a flow rate of 1 mL/min. The method’s validity was established with ICH \(\:{\text{Q}}_{2}{\text{R}}_{1}\) regulations. Excellent linear correlation (r = 0.9999) was established within concentration ranges lies between 1 and 50 µg/mL and 0.5–50 µg/mL with high percent found of 100.04 ± 0.82 and 99.99 ± 1.01 for CFX and ORN, respectively. The approach exhibited high precision (% RDS < 2) and sensitivity with detection limits of 0.07 and 0.09 µg/mL and quantification limits of 0.21 and 0.28 µg/mL for CFX and ORN, respectively. Several metrics evidenced the method’s greenness and sustainability profile.