Proteomics and UHPLC-DAD-Q/Orbitrap-MS used to identify impurities in andrographolide.
UHPLC-DAD-Q/Orbitrap-MS
andrographolide API
impurity
proteomics
residual protein
Journal
Phytochemical analysis : PCA
ISSN: 1099-1565
Titre abrégé: Phytochem Anal
Pays: England
ID NLM: 9200492
Informations de publication
Date de publication:
Jul 2022
Jul 2022
Historique:
revised:
21
02
2022
received:
17
01
2022
accepted:
09
03
2022
pubmed:
24
3
2022
medline:
7
7
2022
entrez:
23
3
2022
Statut:
ppublish
Résumé
Andrographolide active pharmaceutical ingredient (API) is a semidiurnal diterpene lactone with significant antipyretic, antiviral, anti-inflammatory and anticancer activities. A large amount of andrographolide API could only be obtained by extraction from Andrographis paniculata. Therefore, there may be related compounds, plant proteins and other impurities in andrographolide API. In order to improve the safety of andrographolide related preparations, it was necessary to clarify the impurities and improve the quality standard of andrographolide API. The related compounds were identified by ultrahigh-performance liquid chromatography with diode-array detector quadrupole Orbitrap mass spectrometry (UHPLC-DAD-Q/Orbitrap-MS), and the residual proteins were determined by ultrafiltration combined with proteomics. The proteomics method included protein extraction, content determination, digestion, desalination and nanoscale liquid chromatography coupled to tandem mass spectrometry (nano LC-MS/MS) analysis. Then, MS results were compared with Andrographis paniculata protein database by Peaks Studio. The results showed that 32 related compounds were putatively identified, of which 30 impurities were identified for the first time. Seven residual proteins together with 11 highly suspected proteins were uniquely identified, including the T1UNN5_ANDPA protein with the highest intensity. This study will provide useful information on the composition of andrographolide API, which is important for the quality control and clinical safety assurance of API and related prescriptions. Reasonable guidance will also be provided on the necessity of ultrafiltration in the production process of related injections.
Substances chimiques
Diterpenes
0
andrographolide
410105JHGR
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
735-745Subventions
Organisme : Natural Science Foundation of China
ID : 82073975
Organisme : National Traditional Chinese Medicine Standardisation Project
ID : ZYBZH-C-JX-41
Informations de copyright
© 2022 John Wiley & Sons, Ltd.
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