Application of a HPLC-Q/TOF Method with Post-column Compensation for Separation and Identification of Polar Impurities in Cytidine Disodium Triphosphate for Injection / Jinqi Zheng, Mingjuan Zhao, Lishi Yang, Yue Chen, Xiao Gu, Qiaoqiao Huang
Background: Cytidine Disodium Triphosphate (CTP-2Na) for injection is mainly used for treating nervous system diseases. Currently, there are few studies focused on the separation and identification of polar impurities in CTP-2Na for injection, which is important for ensuring drug safety and efficacy. Objective: The study aimed to establish an HPLC-Q/TOF method for the separation and identification of polar impurities in CTP-2Na for injection. Methods: Chromatographic separation was achieved on a Waters Atlantis T3 column using 5 mM aqueous ammonium acetate solution as the mobile phase in an isocratic elution mode. A postcolumn compensation technology was used to improve the ionization efficiency of impurities in the spray chamber. Results: Three polar impurities (disodium cytidine tetraphosphate, disodium cytidine diphosphate, disodium cytidine monophosphate) were detected in CTP-2Na for injection. The former one is probably the overreaction product during the production of CTP-2Na, the latter two were reported as degradation products. The fragmentation patterns of cytidine phosphate compounds in negative ion mode are summarized. Conclusion: This study provides a good reference for the separation and identification of polar impurities in nucleotide drugs.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
Current pharmaceutical analysis - 18(2022), 5, Seite 7 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zheng, Jinqi [VerfasserIn] |
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| Links: |
FID Access [lizenzpflichtig] |
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| Umfang: |
1 Online-Ressource (7 p) |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Application of a HPLC-Q/TOF Method with Post-column Compensation for Separation and Identification of Polar Impurities in Cytidine Disodium Triphosphate for Injection |c Jinqi Zheng, Mingjuan Zhao, Lishi Yang, Yue Chen, Xiao Gu, Qiaoqiao Huang |
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| 520 | |a Background: Cytidine Disodium Triphosphate (CTP-2Na) for injection is mainly used for treating nervous system diseases. Currently, there are few studies focused on the separation and identification of polar impurities in CTP-2Na for injection, which is important for ensuring drug safety and efficacy. Objective: The study aimed to establish an HPLC-Q/TOF method for the separation and identification of polar impurities in CTP-2Na for injection. Methods: Chromatographic separation was achieved on a Waters Atlantis T3 column using 5 mM aqueous ammonium acetate solution as the mobile phase in an isocratic elution mode. A postcolumn compensation technology was used to improve the ionization efficiency of impurities in the spray chamber. Results: Three polar impurities (disodium cytidine tetraphosphate, disodium cytidine diphosphate, disodium cytidine monophosphate) were detected in CTP-2Na for injection. The former one is probably the overreaction product during the production of CTP-2Na, the latter two were reported as degradation products. The fragmentation patterns of cytidine phosphate compounds in negative ion mode are summarized. Conclusion: This study provides a good reference for the separation and identification of polar impurities in nucleotide drugs | ||
| 700 | 1 | |a Zhao, Mingjuan |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Lishi |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yue |e verfasserin |4 aut | |
| 700 | 1 | |a Gu, Xiao |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Qiaoqiao |e verfasserin |4 aut | |
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