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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

Application of a HPLC-Q/TOF Method with Post-column Compensation for Separation and Identification of Polar Impurities in Cytidine Disodium Triphosphate for Injection

Author(s): Jinqi Zheng, Mingjuan Zhao, Lishi Yang, Yue Chen, Xiao Gu* and Qiaoqiao Huang*

Volume 18, Issue 5, 2022

Published on: 13 January, 2022

Page: [535 - 541] Pages: 7

DOI: 10.2174/1573412918666211214095347

Price: $65

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.

Keywords: Cytidine disodium triphosphate for injection, HPLC-Q/TOF, Post-column compensation, impurity identification, polar impurity, T3 column.

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