Development and validation of a dissolution method for a BCS class IV drug tadalafil

Abstract

The present study describes the development and validation of a dissolution method for tadalafil, a Biopharmaceutical Classification System class II drug. 0.1 N hydrochloric acid (HCl)+0.5% sodium lauryl sulphate (SLS), pH 4.5-acetate buffer+0.5% SLS and pH 6.8phosphate buffer+0.5% SLS were tested as dissolution medium, and influences of apparatus, and rotation speed were evaluated. Samples were analyzed by UV spectrophotometric method at 225 nm. The results also shows a better dissolution profile using pH 6.8phosphate buffer + 0.5% SLS as medium and paddle as apparatus is a speed of 100 rpm. The conditions that allowed dissolution determination were USP type II apparatus at 100 rpm, containing 900 mL of pH 6.8phosphate buffer+0.5% SLS as dissolution medium, with analysis at wavelength of 225 nm. Samples were analyzed by UV spectrophotometric method and validated as per ICH guidelines, showing specificity, linearity, precision and accuracy.