Asian Journal of Pharmaceutical Analysis
  • Year: 2015
  • Volume: 5
  • Issue: 4

Analytical UV Spectroscopic Method Development and Validation for the Estimation of Mycophenolate Mofetil

Department of Pharmaceutical Analysis and Quality Assurance, Vijaya Institute of Pharmaceutical Sciences for Womenn. NH-5, Enikepadu, Vijayawada-521 108

Online published on 29 January, 2016.

Abstract

A simple, precise, accurate UV-spectroscopic method was developed and validated for the determination of Mycophenolate Mofetil in bulk and dosage form using solvents like methanol for dissolving the drug and acetate buffer of pH-3.5 for dilutions. At the λmaxof 250nm, it was proved linear in the range 10–50 μg/ml, and exhibit good correlation coefficient (R2 =0.995) and excellent mean recovery (99.990–100.014). The developed method was validated for accuracy, precision, robustness, ruggedness according to ICH guidelines. All these parameters showed adaptability of the method for the quality control analysis of Mycophenolate Mofetil in bulk and in marketed formulation.

Keywords

Mycophenolate Mofetil, UV-Spectroscopy, Acetate buffer, Validation