Objective: To establish a pre-column derivatization high performance liquid chromatography-mass spectrometry to determine biogenic amines in osteopeptide injections and determine the changes of biogenic amines after the stability influence factor test and accelerated test. Methods: The osteopeptide injections were separated by a ZORBAX SB-C18 chromatographic column and gradient elution after derivatization by dansyl chloride. Ten kinds of biogenic amines was determined by mass spectrometry with electrospray ion source and multiple reaction monitoring in positive mode. The osteopeptide injections were placed under high temperature, strong light and accelerated experimental conditions to inspect the stability of biogenic amines. Results: Method validation showed that the linear relationship of 10 biological amines was good, and the correlation coefficients were higher than 0.990. The detection limits were 0.01-0.10 ng·mL-1, the quantitation limits were 0.05-0.30 ng·mL-1. Good accuracy, repeatability and durability were obtained. Under different conditions, the changes of biogenic amines in osteopeptide injections were significant. The accumulation of putrescine increased under high temperature, while spermine and spermidine decreased. The biogenic amines were unstable under strong light and accelerated test. Conclusion: Method validation shows that the method can be applicable to simultaneous determine 10 biogenic amines in osteopeptide injections. It provided a reference to establish and improve the quality standards of biogenic amines in osteopeptide and other drugs. In addition, the research of the stability of biological amines shows that high temperature and strong light will affect the stability of biogenic amines. Therefore, quality control and supervision should be strengthened during drug production and storage to ensure the stability of drug.
LIN Xin-li, WU Chang, TAN Li, MENG Chang-hong, LU Yi-hong, WANG Yu-xin, SHI Qing-shui
. Research on determination and stability of 10 biogenic amines in osteopeptide injections based on HPLC-MS/MS with pre-column derivatization*[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(3)
: 405
-418
.
DOI: 10.16155/j.0254-1793.2024.03.05
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