Rituximab, sold under the brand name Mabthera® / Rituxan® among others, is a medication used to treat certain autoimmune diseases and types of cancer. Rituximab is an intravenous drug that is used to treat rheumatoid arthritis and B-cell non-Hodgkin's lymphoma. Rituximab also is combined with methotrexate (Rheumatrex, Trexall) to treat rheumatoid arthritis in patients who have failed other biologic medications, such as infliximab (Remicade), etanercept (Enbrel), or adalimumab (Humira).

This study was performed to prepare and establish standard operating procedure (SOP) for improve analytical techniques of Rituximab by Liquid chromatography -mass spectrometry-based analytical method. For this purpose, we developed analytical method for protein drug analysis required for the protein structure analysis and performed method validation based on ICH guideline.