离子色谱法测定甘油果糖氯化钠注射液中氯化钠含量  

Content Determination of Sodium Chloride in Glycerol Fructose and Sodium Chloride Injection by Ion Chromatography

作　　者：邓杰 周长明 丁锐 张雪艳 DENG Jie;ZHOU Changming;DING Rui;ZHANG Xueyan(Beijing Institute for Drug Control·NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drug·Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing,China 102206)

机构地区：[1]北京市药品检验研究院·国家药品监督管理局创新药物安全研究与评价重点实验室·中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国药业》2024年第5期86-89,共4页China Pharmaceuticals

摘　　要：目的建立测定甘油果糖氯化钠注射液中氯化钠含量的离子色谱法。方法色谱柱为Dionex IonPacTM CS12A分析柱(250 mm×4 mm,8μm)和Dionex IonPacTM CG12A保护柱(50 mm×4 mm,8μm),淋洗液为25 mmol/L甲烷磺酸溶液,流速为1.0 mL/min,柱温为35℃,进样量为25μL,采用电导检测器,抑制器电流为79 mA。结果氯化钠的质量浓度在0.93~74.59μg/mL范围内与峰面积线性关系良好(r=0.9996,n=6);检测限为0.01μg/mL,定量限为0.03μg/mL;稳定性、重复性试验结果的RSD均小于1.0%(n=6);平均加样回收率为99.48%,RSD为1.31%(n=9)。样品中氯化钠含量为100.63%~105.10%。结论该方法操作简单、重复性好、准确度高,可用于甘油果糖氯化钠注射液中氯化钠的含量测定。Objective To establish an ion chromatography method for the content determination of sodium chloride in Glycerol Fructose and Sodium Chloride Injection.Methods The chromatographic column was Dionex IonPacTM CS12A analytical column(250 mm×4 mm,8μm),and the Dionex IonPacTM CG12A protective column(50 mm×4 mm,8μm),the eluent was 25 mmol/L methane sulfonic acid solution,the flow rate was 1.0 mL/min,the column temperature was 35℃,the injection volume was 25μL,and the conductivity detector was adopted with suppressor current of 79 mA.Results The linear range of sodium chloride was 0.93-74.59μg/mL(r=0.9996,n=6).The limit of detection(LOD)was 0.01μg/mL,and the limit of quantification(LOQ)was 0.03μg/mL.The RSDs of stability and repeatability tests were all lower than 1.0%(n=6).The average recovery rate of sodium chloride was 99.48%with an RSD of 1.31%(n=9).The content of sodium chloride in samples was in the range of 100.63%-105.10%.Conclusion The method is simple,reproducible,and highly accurate,which can be used for the content determination of sodium chloride in Glycerol Fructose and Sodium Chloride Injection.

关 键 词：氯化钠 离子色谱法 甘油果糖氯化钠注射液 含量测定 

分 类 号：R927.2[医药卫生—药学] R971