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<p>Enmetazobactam and cefepime were determined quantitatively in bulk materials and pharmaceutical formulation using a quick, simple, accurate, QbD HPLC Greenness approach. Greenness measurement evaluates how environmentally benign an analytical method is across its life cycle by applying Green Analytical Chemistry (GAC) principles to quantify impacts from solvents/reagents (toxicity and amounts), waste generation, energy use, sample throughput, miniaturization, and automation. Separation was accomplished by using Box-Behnken design by varying column temperature, flow rate and ratio of propylene carbonate. Chromatographic separation was done using a Waters X-Bridge Phenyl column (250 × 4.6&#xa0;mm, 5&#xa0;μm) utilized upon an e2695 system from Waters Alliance. 0.1% formic acid and propylene carbonate 30:70 (v/v) flow rate at 1.0 mL/min. For detection at 281&#xa0;nm a photodiode array detector was put into operation. Linearity was performed with 12.5–75&#xa0;µg/mL and 50–300&#xa0;µg/mL for enmetazobactam and cefepime with correlation coefficient of 0.99988 and 0.99953 respectively. System suitability parameters fulfilled the required criteria displaying more than 2000 theoretical plates and a tailing factor below 2 over both drugs. Peak area repeatability was confirmed with %RSD consistently below 2.0. Forced degradation is carried out and found degradation within limits. Greenness measurement evaluates how environmentally benign an analytical method is across its life cycle by applying Green Analytical Chemistry (GAC) principles to quantify impacts from solvents/reagents (toxicity and amounts), waste generation, energy use, sample throughput, miniaturization, and automation. AGREE have a favorable greenness score of 0.83, blueness score of 77.5 and MoGAPI score of 77. After being verified in accordance with ICH requirements, the method was found to be exact, accurate, economical, robust, and appropriate for routine quantification and stability evaluation of cefepime and enmetazobactam.</p> Graphical abstract <p></p>

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Quality by design-driven RP-HPLC stability indicating method for concurrent estimation of enmetazobactam and cefepime in bulk and dosage form: a greenness and blueness approach

  • 期刊论文

  • 发表日期：

    2026年4月21日

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  • Anusha Gandi,
  • Dilip Kumar Rajana,
  • Poojitha Saripilli,
  • Vasudha Dadi

摘要

Enmetazobactam and cefepime were determined quantitatively in bulk materials and pharmaceutical formulation using a quick, simple, accurate, QbD HPLC Greenness approach. Greenness measurement evaluates how environmentally benign an analytical method is across its life cycle by applying Green Analytical Chemistry (GAC) principles to quantify impacts from solvents/reagents (toxicity and amounts), waste generation, energy use, sample throughput, miniaturization, and automation. Separation was accomplished by using Box-Behnken design by varying column temperature, flow rate and ratio of propylene carbonate. Chromatographic separation was done using a Waters X-Bridge Phenyl column (250 × 4.6 mm, 5 μm) utilized upon an e2695 system from Waters Alliance. 0.1% formic acid and propylene carbonate 30:70 (v/v) flow rate at 1.0 mL/min. For detection at 281 nm a photodiode array detector was put into operation. Linearity was performed with 12.5–75 µg/mL and 50–300 µg/mL for enmetazobactam and cefepime with correlation coefficient of 0.99988 and 0.99953 respectively. System suitability parameters fulfilled the required criteria displaying more than 2000 theoretical plates and a tailing factor below 2 over both drugs. Peak area repeatability was confirmed with %RSD consistently below 2.0. Forced degradation is carried out and found degradation within limits. Greenness measurement evaluates how environmentally benign an analytical method is across its life cycle by applying Green Analytical Chemistry (GAC) principles to quantify impacts from solvents/reagents (toxicity and amounts), waste generation, energy use, sample throughput, miniaturization, and automation. AGREE have a favorable greenness score of 0.83, blueness score of 77.5 and MoGAPI score of 77. After being verified in accordance with ICH requirements, the method was found to be exact, accurate, economical, robust, and appropriate for routine quantification and stability evaluation of cefepime and enmetazobactam.

Graphical abstract