Method Development and Validation of Mycophenolate Mofetil by RP-HPLC

Rubina Kauser, M. Mushraff Ali Khan, Airaj Mahajabeen, Farhana Shaheen, Salma Begum
MRM College of Pharmacy, Chintapalliguda, Ibrahimpatnam, R.R District-501510

A B S T R A C T
Reversed-phase high-performance liquid chromatography (RP-HPLC) involves the separation of molecules on the basis of hydrophobicity. The separation depends on the hydrophobic binding of the solute molecule from the mobile phase to the immobilized hydrophobic ligands attached to the stationary phase, i.e., the sorbent. A schematic diagram showing the binding of a peptide or a protein to a reversed-phase surface. The present objective is to develop a new simple and rapid analytical method to estimate Mycophenolate mofetil in bulk form by hplc method. Hence, on the basis of literature survey it was thought to develop a precise, accurate, simple and reliable method for the estimation. Validation of the method will be done in accordance with ICH guidelines for the assay of active ingredients. The methods will be validated for parameters like accuracy, linearity, precision, robustness, and system suitability. These proposed methods are suitable for the pharmaceutical analysis in analytical laboratories.
Keywords: Mycophenolate mofetil, RP-HPLC, ICH guidelines