Development and Validation of UV Spectrophotometric Methods for Estimation of Mycophenolate Sodium in Bulk and Pharmaceutical Formulations

摘要

Three simple, economical, precise and accurate UV Spectrophotometric methods have been developed for the estimation of Mycophenolate sodium in bulk and pharmaceutical formulations. Method A involves measurement of absorbance of solution at 250.23 nm in methanol. Method B involves measurement of integrated area under curve in the wavelength range of 248.07 nm - 250.03 nm and is used to construct calibration curve. Method C is first order derivative spectroscopy method, in which first order derivative amplitude at 258.42 nm is measured. Linearity for detector response was observed in the concentration range of 10 - 50 μg/ml for all the three methods in methanol. The results of analysis have been validated as per ICH analytical method validation guidelines. Accuracy, precision and recovery studies were carried which confirmed the validity of the proposed methods.