Abstract

DEVELOPMENT OF ASSAY METHOD FOR MYCOPHENOLATE MOFETIL IN PHARMACEUTICAL DOSAGE FORM

Mehta Hiralben Satishchandra*, Dr. Indrajeet Singhvi and Dr. Hasumati Raj

Abstract

A simple, rapid and reproducible high performance reverse phase liquid chromatographic method has been developed for quantitative estimation of Mycophenolate mofetil in tablets form using a, Phenomenex 250 mm x 4.9 mm C18 , 5 μm, inertsil and UV detection at 250nm. The isocratic elution was used to quantify the analyte and the mobile phase was Acetonitrile: acetate buffer (40:60) was pumped at 1.0 mL/min. The method was linear between 50-300 μg/mL, statistically validated for its linearity, precision and accuracy. It was found that the excipients in the commercial tablet did not interfere with the method.

Keywords: HPLC, Mycophenolate mofetil Validation ICH guidelines.