Chronic obstructive pulmonary disease (COPD) remains a pressing global health challenge, exacerbated by increasing pollution and rapid modernization. Addressing this, researchers have developed a novel analytical method for Ensifentrine (EFT), a promising dual inhibitor targeting airway inflammation and bronchodilation, pivotal in COPD treatment.
Method Development and Validation
Leveraging Analytical Quality-by-Design (AQbD) principles, the team utilized Design-Expert software alongside a central composite design to optimize the Reverse Phase Ultra Performance Liquid Chromatography (RP-UPLC) method. The optimized conditions featured isocratic separation on an ACQUITY UPLC HSS C18 SB column maintained at ambient temperature. The mobile phase comprised 0.01 N KH2PO4 (pH 5.4) and acetonitrile in a 66.4:33.6 v/v ratio, with a flow rate of 0.27 mL/min and PDA detection set at 272.0 nm. Validation according to International Council for Harmonisation (ICH) guidelines demonstrated excellent linearity (r² = 0.9997) within the 3.75-22.5 µg/mL range, alongside a limit of detection (LOD) of 3.3 µg/mL and a limit of quantification (LOQ) of 10 µg/mL. The method proved effective for analyzing bulk materials and pharmaceutical formulations, ensuring reliability and precision.
Environmental Sustainability Assessment
Adhering to Green Analytical Chemistry (GAC) principles, the method’s environmental impact was meticulously evaluated using tools such as ComplexMoGAPI, AGREE, BAGI, Green certificate-modified Eco-scale, and ChlorTox Scale. The evaluation highlighted the method’s minimal ecological footprint, further supported by the EVG method assessment showcased in a comprehensive radar chart.
- The integration of AQbD and GAC principles ensures both analytical robustness and environmental responsibility.
- The developed RP-UPLC method offers a reliable and sustainable approach for Ensifentrine quantification.
- Successful application to various formulations underscores the method’s versatility and practicality in pharmaceutical settings.
The introduction of this RP-UPLC method marks a significant advancement in the analytical processing of COPD medications. By harmonizing stringent validation standards with eco-friendly practices, the research not only enhances the accuracy and efficiency of Ensifentrine quantification but also sets a benchmark for sustainable methodologies in pharmaceutical sciences.
This innovative approach provides valuable insights for laboratories aiming to adopt greener practices without compromising on analytical quality. Future research can build upon this foundation, exploring the application of AQbD and GAC principles to other pharmaceutical compounds, thereby fostering a more sustainable and efficient pharmaceutical industry.
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