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Optimized and validated RP-UPLC method for the study of forced degradation and determination of mycophenolate mofetil in tablet dosage forms

T.Vijaya Baskara Reddy, G.Ramu, C.Rambabu

A simple, sensitive, selective and fast reverse phase ultra performance liquid chromatographic (RP-UPLC) method is developed for the determination of mycophenolate mofetil (MMF) in tablet dosage forms and to study the degradation products ofmycophenolate mofetil in forced degradation. The chromatographic separation is achieved on a Waters Acquity UPLC system equipped with auto sampler and PDAdetector (2996).Avolume of 6 µl of the standard or test is injected into a symmetry C18 (2.1 x 100mm, 1.7 m, Make: BEH) column, the components are eluted by using mobile phase of potassium dihydrogen phosphate buffer of pH=4.0 and acetonitrile in the ratio 35:65 v/v at a flowrate of 0.4ml /min. for a short runtimeof2.40min. and the components are monitored at a detection wavelength of 216 nm. The systemsuitability parameters are found to be with in the limits of acceptance with retention time of 0.717min. The linearity limits, correlation coefficient, LODandLOQare found to be 2.5-15ìg/ml, 0.9998,0.0521µg/ml and 0.171µg/ ml respectively. Forced degradation studies are also performed for the drug sample by subjecting the drug to acid hydrolysis, base hydrolysis, oxidation, photolytic and thermal decomposition and found to be stable. The developed method is successfully applied for the analysis of pharmaceutical formulations and the mean percent of the recovery of the drug is found to be 99.2.