Seung-Hyun Park, Joo-Eun Kim
Erectile dysfunction (ED) is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory performance for a duration of >3 months. However, chewable tadalafil formulations for treating ED and corresponding dissolution analysis methods for their quantification are lacking. Therefore, this study aims to investigate Quality by Design considerations for developing a reversed-phase high-performance liquid chromatography method. The test method was designed to perform a quantitative dissolution analysis of tadalafil chewable tablets to enhance medication compliance. This method required an Agilent C8 column (4.6 × 5.0 cm, 5 μm) as the stationary phase and a mobile phase comprising a 1:1 methanol-water mixture. The column temperature and detection wavelength were maintained at 40°C and 225 nm, respectively. The development and validation of the dissolution method resulted in a relative standard deviation of 0.03% for system suitability, assessed in a test solution containing a solubilizer. The test method demonstrated specificity by clearly distinguishing the active pharmaceutical ingredient from excipients. Tadalafil accuracy was confirmed with an average recovery rate of 100.22%, and the precision showed a relative standard deviation of 0.35%. Excellent linearity (R2 = 1.000) was observed over the concentration range of 1.5 μg/mL to 9.0 μg/mL. Additionally, the detection and quantification limits for tadalafil were 0.003 μg/mL and 0.008 μg/mL, respectively. The developed method facilitated rapid quantification of tadalafil in chewable tablets, completing each run within 5 min and reducing analysis time by ~60% compared to conventional methods. Additionally, reagent consumption and operational costs were reduced by ~45%, improving overall efficiency. These findings validate the suitability of the method for reliable industrial quality control of tadalafil chewable tablets and new formulations.