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

Francine Regina Zachow Philippsen, Brunna Ricci Falcao, Letícia de Melo Teixeira, Tiago Rafael Sausen

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.

Keywords


Dissolution; BCS Class IV drug; Validation

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DOI: https://doi.org/10.7439/ijapa.v7i2.4155

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