Objective: To develop a method for the determination of seven kinds of biogenic amines, including tryptamine, 2-phenylethylamine, putrescine, cadaverine, histamine, tyramine and spermidine in thymopolypeptides for injection, ossotide injection, salmon calcitonin injection, glutathione for injection, transfer factor oral solution and transfer factor capsules by RP-HPLC with pre-column derivatization. Methods: Samples were dissolved in 0.1 mol·L-1 hydrochloric acid solution and determined by RP-HPLC with dansyl chloride as derivatization reagent.The experiment was performed on a C18 column(250 mm×4.6 mm, 5 μm) with gradient elution(0-21 min, 70%A→50%A; 21-25 min, 50%A→30%A; 25-60 min, 30%A; 60-70 min, 30%A→70%A) using 0.01 mol·L-1 ammonium acetate solution containing 0.1% aceticacid(A)-acetonitrile(B) as the mobile phase at a flow rate of 1.0 mL·min-1.The detection wavelength was 254 nm. The column temperature was 35 ℃. Results: The calibration curves were linear in the rangs of 0.1-50 mg·L-1(r>0.999) for tryptamine, 2-phenylethylamine, cadaverine, tyramine and spermidine,0.06-31.91 mg·L-1(r>0.999) for putrescine,0.1-26.12 mg·L-1(r>0.999) for histamine.The average recoveries varied from 73.6% to 104.0%. The type and content of biogenic amines were the highest in thymopolypeptides for injection, followed by transfer factor preparation. Only histamine was detected in ossotide injection, and no biogenic amines were detected in salmon calcitonin injection and glutathione for injection. Putrescine, cadaverine, histamine, tyramine and spermidine were found in thymopolypeptides for injection.The highest contents of histamine, putrescine in the thymopolypeptides for injection of enterprise A were about 0.113% and 0.159%, respectively. The contents of cadaverine, tyramine and spermidine in enterprise B were higher, about 0.373%, 0.363% and 0.090%, respectively. Putrescine, cadaverine, tyramine and spermidine were detected in transfer factor oral solution and transfer factor capsules. Conclusion: The method is accurate and reliable,sensitive, reproducible and easy to operate.It could be applied in the detection of the biogenic amines in polypeptide drugs.
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