@article{CHEN2025, 
author = {Yimiao CHEN and Xiang ZHANG and Jinhui WU and Yuye Huang},
title = {Establishment and validation of the determination method for the related substances in carbetocin injection},
year = {2025},
journal = {Journal of China Pharmaceutical University},
volume = {56},
number = {1},
pages = {65-72},
keywords = {high performance liquid chromatography, related substances, carbetocin injection},
url = {https://www.sciopen.com/article/10.11665/j.issn.1000-5048.2024062603},
doi = {10.11665/j.issn.1000-5048.2024062603},
abstract = {An HPLC analytical method was developed to determine the related substances in carbetocin injection. The method was performed on a Waters Xbridge C18 column (150 mm×3 mm, 3.5 μm) with 0.30 mg/mL ammonium acetate-19% acetonitrile aqueous solution as mobile phase A and mobile phase A-acetonitrile (1∶1) as mobile phase B. The detection wavelength was 220 nm. Gradient elution was performed at the flow rate of 0.8 mL/min and the column temperature of 60℃. The method was validated for system applicability, specificity, linearity and range, accuracy, with the results that the 9 impurities of carbetocin injection showed good linearity (R²>0.999) with peak area in their respective concentration range, and that the method had good precision (RSD<5%). This method is suitable for the simultaneous determination of carbetocin and its 9 impurities in carbetocin injection and can provide a theoretical basis for the quality control of the carbetocin injection.}
}