| Summary: | The combination of Glycopyrronium, Fluticasone, and Vilanterol is utilized to manage chronic obstructive pulmonary disease (COPD) and mitigate asthma symptoms. Glycopyrronium functions as an anticholinergic compound, Fluticasone serves as a corticosteroid that mitigates inflammation, and Vilanterol operates as a long-acting beta-agonist that facilitates the relaxation of the bronchial passages. The simultaneous quantification of Glycopyrronium, Vilanterol, and Fluticasone was accomplished through the utilization of Ultra-High-Performance Liquid Chromatography (UHPLC) employing a Symmetry Shield C18 column (4.6 mm x 100 mm ID, 2.6 µm particle size), with a flow rate of 0.6 mL/min, and a gradient elution employing pH 3.0 Ammonium Formate as mobile phase A and ethanol as mobile phase B. By the guidelines delineated by the International Conference on Harmonization (ICH) Q2, method validation encompassed specificity (with the purity angle for the three chromatographic peaks exceeding the purity threshold under all degradation conditions), linearity (exhibiting an R² value greater than 0.999 from the lower limit of quantification to 200 %), accuracy (with recovery rates ranging from 95 % to 105 %), robustness (the influence of variations in mobile phase buffer pH, column temperature, and flow rate was scrutinized utilizing Analytical Quality by Design principles), and assessments of method precision. The Green Analytical Procedure Index (GAPI), Analytical Greenness (AGREE), and analytical eco-scale evaluations substantiated the method's advantageous characteristics regarding environmental sustainability.
|
|---|
