Development and Validation of Visible Spectrophoto Metric Method of Mycophenolate Mofetil in Bulk and Pharmaceutical Dosage form

Abstract

A simple, sensitive and accurate spectrophotometric method has been developed for the estimation of mycophenolate mofetil in bulk and pharmaceutical formulation. The method is based on the formation of green colored chromogen with 3-methyl-2-benzothiazolinone-hydrazonehydrochloride reagent in the presence of 0.03M ferric chloride and obeys beer's law in the range of 2-10 μg/mL exhibiting the maximum absorbance at 659 nm. The limit of detection and quantification were found to be 0.87 μg/mL and 2.66 μg/ mL respectively. The calibration curve demonstrated a linear relationship between the absorbance and concentration, with the correlation coefficient higher than 0.999. The regression equation of the curve is Y=0.082x-0.019. The method is fully validated according to ICH guidelines.