Micelle-enhanced green spectrofluorimetric method for the determination of avanafil in dosage forms and spiked human plasma with sustainability assessment
Aya Barseem, Reem H. Obaydo, Samar H. Elagamy
Abstract
A simple, rapid, eco-friendly, and highly sensitive micelle-enhanced spectrofluorimetric method was developed for the determination of Avanafil (AVA) in pharmaceutical formulations. The method is based on the enhancement of AVA native fluorescence through micelle formation with the anionic surfactant sodium dodecyl sulfate (SDS). The fluorescence intensity significantly increased upon micellar interaction, and measurements were recorded at 385 nm following excitation at 310 nm. The method was carefully optimized with respect to critical parameters, including the pH of the system, the volume of SDS, and the type of diluting solvent to achieve maximum sensitivity and reproducibility. A linear response was obtained over the concentration range of 100–1200 ng mL -1 , with a detection limit of 20 ng mL -1 and a quantitation limit of 70 ng mL -1 . The developed method was applied for the determination of the drug in spiked human plasma samples with an average percent recovery of 98.65%. Therefore, it is suitable for pharmacokinetic studies and therapeutic monitoring of AVA. The proposed method was validated according to ICH guidelines, demonstrating excellent linearity, accuracy, precision, and robustness. Statistical comparison with a previously reported HPLC method revealed no significant differences in accuracy or precision, confirming the reliability of the proposed approach. Additionally, the greenness and whiteness of the method were evaluated using established assessment tools, highlighting its environmental sustainability compared to other reported methods.