QbD consideration for developing and validating the dissolution test method for quantitative analysis of tadalafil chewable tablets
Abstract
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…
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