NEW STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF MYCOPHENOLATE MOFETIL CAPSULE IN PHARMACEUTICAL DOSAGE FORM

Abstract

A simple stability indicating reverse phase high performance liquid chromatographic (RP-HPLC) method was developed for separation of Mycophenolate mofetil with impurity-c and validated for the determination Mycophenolate mofetil activity in Mycophenolate mofetil capsule formulation. Separation of Mycophenolate mofetil was successfully achieved on Hypersil BDS C18(250mm x 4.6mm x 5.0 µm) column utilizing phosphate buffer (7.0 pH) and acetonitrile (65:35 v/v), as mobile phase at a flow rate of 2mL/min and the eluate was monitored using PDA Detector at 250 nm. The retention time was found to be 6.520. The developed method was validated as per ICH guidelines for specificity, linearity and range, precision, accuracy, robustness and ruggedness. The results of all the validation parameters were well within their acceptance values. The method gave good recovery in the range of 97.0% to 103.0% for the given Capsule form when it was applied for its determination in pharmaceutical dosage form