Mr. A.U. Manjare
Department of Quality Assurance, SVPM’s College Of Pharmacy, Malegaon (Maharashtra) India.
Mr. Kale R.N.
Department of Quality Assurance, SVPM’s College Of Pharmacy, Malegaon (Maharashtra) India.
Abstract
Mycophenolic acid is an anti-metabolite immunosuppressant. It also inhibits the enzyme inosine monophosphate dehydrogenase; essential for purine synthesis. High performance liquid chromatography (HPLC) and the UV are an essential analytical tools in assessing drug product. HPLC methods should be able to isolate, detect, and enumerate the various drugs and drug associated degradants that can form on storage, or manufacturing. It should also detect and enumerate any drugs and drug-related impurities that may be introduced during synthesis. Validation is the process of establishing the performance characteristics and limits of a method and identification of the effects which may change these features and to what extent. This article discusses the current and potential uses of the drug mycophenolic acid as well as the plans and the subjects related to designing UV and HPLC method for development and validation.
Keywords: Mycophenolic acid, Immunosuppressant, HPLC, UV, Validation