FT-IR method development and validation for quantitative estimation of Mycophenolate mofetil bulk and tablet dosage form

Abstract

A simple precise and accurate method was developed and validated for the quantitative estimation Mycophenolate Mofetil in bulk and pharmaceutical formulations. For the determination of the active pharmaceutical ingredients (API), KBr pellets containing known amount of standards and samples were used for acquisition of the FTIR spectra. The method involves the measurement of peak of carbonyl group at 1739cm-1. Linearity was observed in the range of 0.010g to 0.050g. The LOD and LOQ were found to be 0.045%w/w and 0.13%w/w respectively. The % RSD value doesn’t exceed 2. The developed method is accurate, precise and easy to use as compared to the chromatographic methods reported in the literature and pharmacopoeia as and are also free from any interference of the excipients matrix. This technique does not use organic solvents, which is one great advantage over the most common analytical methods. This fact contributes to minimize the generation of organic solvent waste by the industry and thereby reduces the impact of its activities on the environment.