Identification of related substances in apixaban tablets by UHPLC-Q-Orbitrap/MS
10.11665/j.issn.1000-5048.2024081401
- VernacularTitle:UHPLC-Q-Orbitrap/MS技术鉴定阿哌沙班片的有关物质
- Author:
Guangyun LYU
1
;
Yiran YAO
;
Danyang XU
;
Shu WANG
;
Bei XIAO
Author Information
1. 南通市食品药品监督检验中心, 南通 226000
- Publication Type:Journal Article
- Keywords:
apixaban;
related substances;
structural identification;
UHPLC-Q-Orbitrap/MS
- From:
Journal of China Pharmaceutical University
2025;56(3):341-349
- CountryChina
- Language:Chinese
-
Abstract:
A UHPLC-Q-Orbitrap/MS method was developed to identify the related substances in apixaban tablets. Complete separation was accomplished with a Waters Xbridge C18 (250 mm×4.6 mm, 5 μm) column by linear gradient elution using a mobile phase consisting of 30 mmol/L ammonium acetate buffer solution (pH 4.50) and acetonitrile. The related substances were successfully characterized through the accurate mass and elemental composition of the parent ions and their product ions determined by electrospray positive ionization high-resolution Q-Orbitrap/MS methods. Under the established analytical condition, apixaban and its related substances were well separated, and 30 related substances were detected and identified by hyphenated techniques in apixaban tablets and their stressed samples. Among them, 11 were known impurities and the rest 19 were unknown related substances identified for the first time in this study. The results obtained are valuable for apixaban manufacturing process optimization and quality control.
