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离子色谱法测定两种阿糖胞苷制剂中的氨含量

Determination of ammonium in two Cytarabine preparations by ion chromatography

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【作者】 宁芳晨刘峰周锐钱广生

【Author】 NING Fangchen;LIU Feng;ZHOU Rui;QIAN Guangsheng;West China School of Pharmacy,Sichuan University;Key Laboratory of in vivo and in vitro Correlation Technology Research for Drug Formulations of the National Medical Products Administration,Sichuan Food and Drug Inspection and Testing Institute;

【通讯作者】 钱广生;

【机构】 四川大学华西药学院四川省药品检测研究院国家药品监督管理局药物制剂体内外相关性技术研究重点实验室

【摘要】 目的 采用离子色谱法测定两种不同剂型阿糖胞苷制剂中的氨含量。方法 采用Dionex IonPac CS12A阳离子交换柱(250 mm×4 mm),Dionex IonPac CG12离子色谱保护柱(50 mm×4 mm);淋洗液为4 mmol·L-1甲磺酸溶液,流速为1.1 mL·min-1,电导检测器,Dionex CERS 300(4 mm)抑制器,抑制电流为13 mA,柱温30℃,池温45℃,进样量25μL。结果 0.12~1.20μg·mL-1氨与峰面积的线性关系良好(r=0.9995);氨在注射用阿糖胞苷、阿糖胞苷注射液中的平均回收率分别为91.55%、93.34%,RSD分别为1.22%、2.94%(n=6)。结论 所用方法专属性高,准确可靠,可用于阿糖胞苷制剂中氨的含量测定。

【Abstract】 OBJECTIVE To determine ammonium in two different kinds of Cytarabine preparations by ion chromatography(IC) method.METHODS The IC method was performed on a Dionex IonPac CS12A(250 mm ×4 mm) cation exchange column and guarded by a Dionex IonPac CG12 column, with 4 mmol·L-1 methanesulfonic acid as eluent, and the flow rate was 1.1 mL·min-1.The detector was conductivity detector with a suppressor( Dionex CERS 300,4 mm),whose suppression current was 13 mA.The temperature of the column and conductivity detector were 30 ℃ and 45 ℃,respectively,and the injection volume was 25 μL.RESULTS The linearity range of ammonium was 0.12-1.20 μg·mL-1(r=0.9995).The average recovery of cytarabine for injection and Cytarabine injection was 91.55% and 93.34%,and the RSD volues were 1.22% and 2.94%(n=6).CONCLUSION The method is specific, accurate and reliable, which is suitable for the determination of ammonium in Cytarabine preparations.

  • 【文献出处】 华西药学杂志 ,West China Journal of Pharmaceutical Sciences , 编辑部邮箱 ,2025年02期
  • 【分类号】O657.7;R927.2
  • 【下载频次】43
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