Identification of related substances in apixaban tablets by UHPLC-Q-Orbitrap/MS

LYU Guangyun; YAO Yiran; XU Danyang; WANG Shu; XIAO Bei

doi:10.11665/j.issn.1000-5048.2024081401

Journal of China Pharmaceutical University > 2025 > 56(3): 341-349. > DOI: 10.11665/j.issn.1000-5048.2024081401

LYU Guangyun, YAO Yiran, XU Danyang, et al. Identification of related substances in apixaban tablets by UHPLC-Q-Orbitrap/MS[J]. J China Pharm Univ, 2025, 56(3): 341 − 349. DOI: 10.11665/j.issn.1000-5048.2024081401

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Identification of related substances in apixaban tablets by UHPLC-Q-Orbitrap/MS

Nantong Food and Drug Control Center, Nantong 226000, China

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This study was supported by the Open Project of the National Medical Products Administration Key Laboratory for Impurity Profile of Chemical Drugs (NMPA-KLIPCD-2023-03)

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Received Date: August 13, 2024
Revised Date: September 08, 2024
Accepted Date: September 24, 2024

Graphical Abstract

Abstract

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.
- apixaban,
- related substances,
- structural identification,
- UHPLC-Q-Orbitrap/MS

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References (14)

References

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