Abstract

A MULTI-PURPOSE RP-HPLC METHOD DEVELOPMENT & VALIDATION OF DIMETHYL FUMARATE DRUG SUBSTANCE AND DRUG PRODUCT: A CONCISE REVIEW

Sridharreddy Kommareddy*, R. S. Nigam and Samit Kumar

ABSTRACT

In pharmaceutical industries, analytical method development, validation and method transfer are the basic significant role, which are continuous and inter-dependent activities associated with the research and development, quality control and quality assurance departments. The analytical method development and validation plays a dynamic role from discovery to manufacture of pharmaceutical drug substance and drug product. To achieve the above objective, high performance liquid chromatography (HPLC) is one of the flexible tools that are utilized to generate the majority of analytical data that is required during the drug development as well as manufacturing process. HPLC methods can be adapted to meet most of the challenges demanded from the scientific, business, and regulatory driving forces during the entire drug development process, from the discovery of the therapeutic compound, to the final commercialization of the product. This review article provides a basic overview of the current available various analytical methods of identification, related substance and assay of dimethyl fumarate drug substance and identification, degradation products and assay of dimethyl fumarate its drug product by using the HPLC technique.

Keywords: RP–HPLC, Dimethyl fumarate, Fumaric acid, Mono-methyl fumarate, Isocratic elution, Method validation and Stability indicating.