- 中国精品科技期刊
- 中国高校百佳科技期刊
- 中国中文核心期刊
- 中国科学引文数据库核心期刊
| Citation: |
CHEN Yimiao, ZHANG Xiang, WU Jinhui, et al. Establishment and validation of the determination method for the related substances in carbetocin injection[J]. J China Pharm Univ, 2025, 56(1): 65 − 72. DOI: 10.11665/j.issn.1000-5048.2024062603
|
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.
| [1] |
Borovac-Pinheiro A, Pacagnella RC, Cecatti JG, et al. Postpartum hemorrhage: new insights for definition and diagnosis[J]. Am J Obstet Gynecol, 2018, 219(2): 162-168. doi: 10.1016/j.ajog.2018.04.013
|
| [2] |
Stämpfli D, Dommrich R, Orbach-Zinger S, et al. An explorative analysis of pharmacovigilance data of oxytocin and its analogue carbetocin, with a focus on haemodynamic adverse effects[J]. Int J Clin Pharm, 2023, 45(4): 922-928. doi: 10.1007/s11096-023-01587-9
|
| [3] |
Liu CY, Tan XY, Zhu DM. The clinical application analysis of carbetoxine in the prevention of bleeding after cesarean section[J]. Heilongjiang Med J(黑龙江医学), 2023, 47(07): 792-794.
|
| [4] |
Yan JY. The Effect of carbetocin and carboprost tromethamine in the treatment of postpartum hemorrhage due to uterine contraction and their influence on the lactation function of the parturient[J]. Med Inf (医学信息), 2020, 33(21): 146-148.
|
| [5] |
Zhang HH. Prescription process development and quality research of carbetocin injection(卡贝缩宫素注射液处方工艺开发及质量研究)[D]. Nanjing: Nanjing University, 2019.
|
| [6] |
Yin LN, Huang YY, Wang C, et al. Development of a novel and stability indicating RP-HPLC-UV method for simultaneous analysis of carbetocin and ten impurities in carbetocin injection products[J]. Chromatographia, 2021, 84(10): 967-978. doi: 10.1007/s10337-021-04083-2
|
| [7] |
Wang SS. Application of two-dimensional liquid chromatography-mass spectrometry in related substances research of peptide drugs(二维液相色谱-质谱联用技术在多肽类药物有关物质研究中的应用)[D]. Nanjing: Nanjing University, 2021.
|
| [8] |
Yang L, Yang G, Deng T. Analysis on clinical application rationality for carbetocin injection[J]. J China Prescr Drug (中国处方药), 2023, 21(3): 68-71.
|
| [9] |
Widmer M, Piaggio G, Nguyen TMH, et al. Heat-stable carbetocin versus oxytocin to prevent hemorrhage after vaginal birth[J]. N Engl J Med, 2018, 379(8): 743-752. doi: 10.1056/NEJMoa1805489
|
| [10] |
Armbruster D, Burke T, Weeks A. Heat-stable carbetocin to prevent postpartum hemorrhage[J]. N Engl J Med, 2018, 379(24): 2380-2381. doi: 10.1056/NEJMc1812692
|
| [11] |
Cook JR, Saxena K, Taylor C, et al. Cost-effectiveness and budget impact of heat-stable carbetocin compared to oxytocin and misoprostol for the prevention of postpartum hemorrhage (PPH) in women giving birth in India[J]. BMC Health Serv Res, 2023, 23(1): 267. doi: 10.1186/s12913-023-09263-4
|
| [12] |
Sanz-Nebot V, Garcés A, Barbosa J. Investigation of crudes of synthesis of carbetocin by liquid chromatography coupled to electrospray ionization mass spectrometry[J]. J Chromatogr A, 1999, 833(2): 267-275. doi: 10.1016/S0021-9673(98)01053-X
|
| [13] |
Sanz-Nebot V, Toro I, Garcés A, et al. Separation and identification of peptide mixtures in a synthesis crude of carbetocin by liquid chromatography/electrospray ionization mass spectrometry[J]. Rapid Commun Mass Spectrom, 1999, 13(23): 2341-2347. doi: 10.1002/(SICI)1097-0231(19991215)13:23<2341::AID-RCM795>3.0.CO;2-9
|
| [14] |
Zhang H, Yang HX, Liang CG, et al. HPLC analysis of carbetocin and its related impurities[J]. Chin J Pharm Anal (药物分析杂志), 2007, 27(10): 1553-1555.
|
| [15] |
Malm M, Madsen I, Kjellström J. Development and stability of a heat-stable formulation of carbetocin for the prevention of postpartum haemorrhage for use in low and middle-income countries[J]. J Pept Sci, 2018, 24(6): e3082. doi: 10.1002/psc.3082
|
| [16] |
Lin SY, Jeng SL. Comparison of ion-pairing and ion-suppressing liquid chromatographic methods for the determination of pyrimethamine and ormetoprim in chicken feed[J]. J Chromatogr Sci, 2002, 40(6): 331-336. doi: 10.1093/chromsci/40.6.331
|
| [17] |
Molnár I, Horváth C. Separation of amino acids and peptides on non-polar stationary phases by high-performance liquid chromatography[J]. J Chromatogr, 1977, 142: 623-640. doi: 10.1016/S0021-9673(01)92073-4
|
Supported by: Beijing Renhe Information Technology Co., Ltd. 
Total visits：301748
DownLoad: