Development and Validation of a UV Spectrophotometric Method of Mycophenolate Mofetil Useful at Preformulation Stage of Microemulsion Formulation

Abstract

The main objective of this work was to develop and validate a simple UV spectrophotometric method to estimate mycophenolate mofetil required at preformulation stage for its microemulsion formulation. Absorption spectrum of the drug was recorded against methanol as a blank. Various analytical parameters such as linearity, limit of detection and quantification, accuracy, precision, stability and robustness were studied. The validated method was applied for solubility studies of the drug in various excipients to explore its microemulsion formulation. The developed method was found to be linear within the range of 5-35µg/ml. The limit of detection and quantification were found to be 0.796µg/ml and 2.412µg/ml, respectively. Other analytical parameters were within the range of ICH Q2 (R1) guidelines of analytical method validation. The developed UV method was successfully used to screen the solubility of few selected oils, surfactants and co-surfactants. The developed UV method of mycophenolate mofeteil can be used successfully for solubility studies required for microemulsion formulation.