Abstract

DETERMINATION OF SOLUBILITY OF TADALAFIL BY SHAKE FLASK METHOD BY EMPLOYING VALIDATED HPLC ANALYTICAL METHOD

Ojaswi Ghadge*, Mitali Samant and Anubha Khale.

Abstract

The main aim of the work was to study the solubility behaviour of the poorly soluble drug from BCS Class IV, Tadalafil. The solubility determination was done by Shake flask method in different solvent systems (Water, Methanol, Water: Methanol, Water: SLS, in buffers of pH 1 to 7.4). The time of shaking was varied between 30 minutes and 48 hours. The time of sedimentation was varied between 1 and 24 hours. Also the study was carried out by repeating the method at different temperatures 25 0C, 37 0C, 50 0C. HPLC method was developed and validated as per ICH guidelines, for analysing samples using solvent system Methanol: Acetonitrile (50:50, tR = 2.6min). From the Shake Flask study, it was found that the shaking time can affect the solubility of API to great extent. For Tadalafil 6 hrs shaking time found to be optimum. Since the maximum solubility of drug was found to be in Water: SLS system, it can be concluded that Water: SLS can be used as dissolution media for the formulation of Tadalafil.

Keywords: Shake Flask method, Tadalafil, Solubility, HPLC.