Stability Indicating and Green Solvent-Assisted Chromatographic Analysis of an Antiviral Drug

A novel, environment friendly high-performance liquid chromatography method for the determination of Ganciclovir in drug and formulations. Current HPLC methods often rely on acetonitrile, a solvent known to pose environmental and health hazards. Despite extensive literature review ganciclovir was estimated using only traditional HPLC solvents no studies were reported using ethanol. The developed method utilizes a simple mobile phase consisting of ethanol and acidic water (pH 3.0) at an optimized ratio of 80:20 v/v. Separation is achieved on a Zorbax eclipse plus C18 column (4.6 × 150 mm, 5 μm) with a flow rate of 1.0 mL/min. The proposed method demonstrates excellent linearity, and precision, assessed by (r² ≥ 0.999) and %RSD by below 2%, with recovery 98–102%. The method’s greenness was evaluated using established assessment tools such as AGREE, GAPI, and COMPLEX GAPI confirming the method’s adherence to 12 green analytical principles. The proposed method’s capability of separation from degradation products and no significant change of peak area and retention time was observed. This study explores the feasibility of substituting the acetonitrile with an eco-friendly greener alternative, ethanol recognized for its low toxicity and environmental impact.

Graphical Abstract