Background: Histamine fixed-immunoglobulin formulations, which consisted of 0.15 µg of histamine dihydrochloride and 12 mg of human immunoglobulin in a vial, are used for anti-allergic treatments, and controlling the amounts of histamine in the formulations is essential to avoid histamine intoxication.
Objective: A high-performance liquid chromatography (HPLC) method for determination of histamine contents of the formulations was established and validated.