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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
【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.
【Key words】 Ion chromatograph; Cytarabine; Ammonium; Content determination; Quality Control;
- 【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