Poster Presenter

Development and Validation of a RP-HPLC Method for Quantification of Mycophenolate Sodium Raw Material and Enteric-Coated Tablets
André Lima de Oliveira Costa; Paula Cristina Rezende Enéas; Tiago Assis Miranda; Cristina Duarte Vianna Soares; Gerson Antônio Pianetti
Brasil


Enteric-coated mycophenolate sodium has this first regulatory approval in Switzerland in 2002. It was developed to reduce the incidence and severity of the gastric side effects of mycophenolate mofetil immediate release tablets used in immunosuppression therapy of post-transplant patients. A high-performance liquid chromatograpy method for quantification of mycophenolate sodium raw material and enteric-coated tablets was developed and validated. The quantification was carried out in a reverse-phase (C8) using a mobile phase composed of methanol and 0.05% fosforic acid (55:45), at flow rate of 1.5 ml/min and diode array detection at 250 nm. The method demonstrated to be selective (degradation products of hydrolysis), precise, accurate and linear. The method showed to be simple, robust and suitable for quality control.