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- Title
Validation of HPLC Method for Determination of Histamine in Human Immunoglobulin Formulations.
- Authors
Michikazu Tanio; Toru Nakamura; Hideki Kusunoki; Kyohei Ideguchi; Kazuyuki Nakashima; Isao Hamaguchi
- Abstract
Background: Histamine fixed-immunoglobulin formulations, which consisted of 0.15 mg of histamine dihydrochloride and 12mg 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. Methods: Histamine extracted from the formulation was labeled with 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate and was analyzed by gradient elution HPLC with UV detection at 260nm. Results: The method showed linearity in the range 0.8–2.4 mM (R>0.999), accuracy (100.1–105.8% recovery), and precision (relative standard deviation ≤ 1.93%). The validated method was applied for five lots of the pharmaceutical, and their histamine contents were determined to be 0.149–0.155 mg/vial. Conclusions: These results indicated that the validated method is useful to control amounts of histamine in biopharmaceutical products. Highlights: The HPLC method was developed for quantitative determination of histamine content of the histamine fixed-immunoglobulin formulations.
- Subjects
HISTAMINE; HIGH performance liquid chromatography; GRADIENT elution (Chromatography)
- Publication
Journal of AOAC International, 2020, Vol 103, Issue 5, p1223
- ISSN
1060-3271
- Publication type
Article
- DOI
10.1093/jaoacint/qsaa017