Application of a HPLC-Q/TOF method with post-column compensation for separation and identification of polar impurities in Cytidine disodium triphosphate for injection
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Published:2021-12-14
Issue:
Volume:18
Page:
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ISSN:1573-4129
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Container-title:Current Pharmaceutical Analysis
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language:en
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Short-container-title:CPA
Author:
Zheng Jinqi1,
Zhao Mingjuan1,
Yang Lishi1,
Chen Yue1,
Gu Xiao1,
Huang Qiaoqiao1
Affiliation:
1. Zhejiang Institute for Food and Drug Control (Key Laboratory of Core Technology for Generic Drug Evaluation, China Drug Administration), Hangzhou, Zhejiang, China
Abstract
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.
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics