TY  - JOUR
AU  - CHEN, Yimiao
AU  - ZHANG, Xiang
AU  - WU, Jinhui
AU  - Huang, Yuye
PY  - 2025
TI  - Establishment and validation of the determination method for the related substances in carbetocin injection
JO  - Journal of China Pharmaceutical University
SN  - 1000-5048
SP  - 65
EP  - 72
VL  - 56
IS  - 1
AB  - 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.
UR  - https://doi.org/10.11665/j.issn.1000-5048.2024062603
DO  - 10.11665/j.issn.1000-5048.2024062603