Abstract

Posaconazole (PSC), a potent broad-spectrum triazole antifungal agent, is widely used in managing invasive fungal infections. Accurate measurement of PSC in pharmaceutical formulations is essential to ensure consistent therapeutic efficacy. Although high-performance liquid chromatography (HPLC) is the gold standard for detecting trace pharmaceutical concentrations, a notable gap remains due to the limited availability of validated HPLC methods specifically for PSC quantification. In this study, a sustainable and validated HPLC method was developed using PSC bulk drug and subsequently applied to quantify it in pharmaceutical formulations. The optimal chromatographic conditions consisted of a mobile phase composed of acetonitrile and water acidified with 0.5% acetic acid (55:45, v/v), a flow rate of 1 mL/min, and an injection volume of 20 µL. The method demonstrated excellent linearity within the concentration range of 0.5–32 µg/mL (R² = 0.9999), with a limit of detection (LOD) and limit of quantification (LOQ) of 0.16 and 0.50 µg/mL, respectively. Accuracy and precision results were within acceptable limits. Sustainability assessments using AGREE and GAPI tools confirmed the eco-friendly nature of the developed method. The validated HPLC method was successfully employed to estimate PSC content in a self-nanoemulsifying drug delivery system (SNEDDS) and during in vitro dissolution studies. Overall, the proposed HPLC method is analytically robust, reproducible, and environmentally sustainable, making it suitable for routine quantification of PSC in both bulk and formulation samples.

Key words: Posaconazole, High-performance Liquid chromatography, Greenness, validation, Stability, SNEDDS