DEVELOPMENT AND VALIDATION OF NOVEL HYDROTROPIC SOLUBILIZATION METHOD FOR SPECTROPHOTOMETRIC DETERMINATION OF MYCOPHENOLATE MOFETIL
The aim of present study was to develop and validate specific and accurate UV spectrophotometric method of Mycophenolate mofetil by using two different hydrotropic solubilizing agents. Objective was to perform solubility studies of Mycophenolate mofetil in the solutions containing urea (0.2 M) and sodium carbonate (0.2 M) as hydrotropic agents and find out the minimum hydrotropic concentration of urea and sodium carbonate for drug Mycophenolate mofetil. The linearity was observed in the concentration range of 10-30 μg/ml. The method was validated and found to be precise. Accuracy (percent recovery) for Mycophenolate mofetil was found to be 98.97-102.72. From the results it was concluded that urea as hydrotropic agent showed best aqueous solubility of Mycophenolate mofetil and all the validation parameters were found within the limits according to ICH guidelines. So that hydrotropic agent urea suitable solvent for increasing the solubility of Mycophenolate mofetil. The proposed method is new, simple, safe, eco-friendly, economic, accurate, cost-effective and can be successfully employed in routine analysis.