离子色谱法检测三磷酸胞苷二钠注射液含量及有关物质

发布时间：2018-04-02 16:01

本文选题：三磷酸胞苷二钠(CTP-Na)　切入点：二磷酸胞苷二钠(CDP-Na)　出处：《药物分析杂志》2015年02期

【摘要】：目的:建立用于三磷酸胞苷二钠注射液含量测定及有关物质检测的离子色谱方法。方法:采用Ion Pac溲AS11-HC(4mm×250 mm)色谱柱,以氢氧化钾为淋洗液,采用梯度洗脱,流速为1.0 m L·min-1,进样量10μL,以带DIONEX AERS溲5004-mm抑制器的电导检测器进行检测,三磷酸胞苷二钠注射液的含量按峰面积以外标法计算,主要降解杂质(二磷酸胞苷二钠、单磷酸胞苷二钠)按加校正因子的主成分自身对照法计算。结果:三磷酸胞苷二钠在0.000 164~1.60 mg·m L-1范围内线性关系良好(r=0.999 8,n=6);平均加样回收率(n=9)为100.1%;三磷酸胞苷二钠对照品溶液在24 h内的稳定性良好(RSD=1.3%);三磷酸胞苷二钠(CTP-Na2)及主要降解杂质二磷酸胞苷二钠(CDP-Na2)、单磷酸胞苷二钠(CMP-Na2)的方法定量限分别为1.6、4.57、6.0 ng,检出限分别为0.50、1.48、1.88 ng。结论:本方法适用于三磷酸胞苷二钠注射液的质量控制。
[Abstract]:Objective: to establish an ion-chromatographic method for the determination of cytidine triphosphate disodium injection and related substances.Methods: a Ion Pac Deutzia AS11-HC(4mm 脳 250mm column was used, potassium hydroxide was used as eluant, gradient elution was used, flow rate was 1.0 mL / min ~ (-1), sample volume was 10 渭 L, and the detector was used with DIONEX AERS 5004-mm suppressor.The content of cytidine disodium triphosphate injection was calculated by external standard method according to the peak area, and the main degradation impurities (cytidine diphosphate disodium diphosphate, cytidine monophosphate disodium monophosphate) were calculated by the principal component autocontrol method with correction factor.The quantification limits of the degradation impurity cytidine disodium diphosphate (CDP-Na _ 2N _ 2) and cytidine monophosphate (CMP-Na _ 2) were 1.6ng, 4.57 ~ 6.0ng, and the detection limits were 0.50,1.48ng and 1.88ngrespectively.Conclusion: this method is suitable for the quality control of cytidine triphosphate disodium injection.
【作者单位】：中国医学科学院医药生物技术研究所;辽宁医学院药学院;烟台东诚药业集团股份有限公司;北京市药品检验所;
【基金】：科技部新药创制重大专项平台(2012ZX09301002-001-019)
【分类号】：R927.2;O657.7

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