A Validated and Rapid HPLC Method for Quantification of Human Serum Albumin in Interferon beta-1a Biopharmaceutical Formulation

Abstract

Multiple sclerosis, or MS, is a long-lasting disease that can affect your brain, spinal cord, and the optic nerves in your eyes. It can cause problems with vision, balance, muscle control, and other basic body functions. IFN-beta treatment reduces the relapse rate in multiple sclerosis (MS), but the exact mechanism of action of the drug has remained elusive. CD73 (ecto-5'-nucleotidase) is an ectoenzyme, which produces adenosine from adenosine monophosphate (AMP) precursor by enzymatic dephosphorylation. In this study, a validated and rapid HPLC method for quantification of human serum albumin in interferon beta-1a biopharmaceutical formulation was developed and linearity, robustness, specificity, accuracy and precision of samples were determined.