阴离子交换色谱法同时测定乳酸钠林格注射液中乳酸钠和总氯含量  

Simultaneous Determination of Sodium Lactate and Total Chlorine in Sodium Lactate Ringer′s Injection by Anion Exchange Chromatography

作　　者：徐浩 朱静 戴冬艳 陈剑秋 XU Hao;ZHU Jing;DAI Dongyan;CHEN Jianqiu(Taizhou Institute for Drug Control,Taizhou,Jiangsu,China 225300)

机构地区：[1]江苏省泰州市药品检验院,江苏泰州225300

出　　处：《中国药业》2024年第20期76-78,共3页China Pharmaceuticals

摘　　要：目的建立同时测定乳酸钠林格注射液中乳酸钠和总氯含量的阴离子交换色谱法。方法分析柱为Dionex IonPac^(TM)AS11-HC柱(250 mm×4 mm),保护柱为AS11-HC柱(50 mm×4 mm),淋洗液为10 mmol/L氢氧化钾溶液,流速为1.0 mL/min,检测器温度为35℃,柱温为30℃,电导检测器,抑制器抑制电流为25 mA,进样量为25μL。结果乳酸根离子、氯离子质量浓度分别在9.97~249.37μg/mL、15.27~381.70μg/mL范围内与峰面积线性关系良好(r=0.9997,1.0000,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为100.74%,100.48%,RSD分别为1.17%,1.53%(n=9)。结论所建立的方法操作简便,灵敏度高,稳定性好,结果准确,可用于测定乳酸钠林格注射液中乳酸钠和总氯的含量。Objective To establish an anion exchange chromatography method for simultaneous determination of sodium lactate and total chlorine contents in Sodium Lactate Ringer′s Injection.Methods The analytical column was Dionex IonPac^(TM) AS11-HC column(250 mm×4 mm),the protective column was AS11-HC column(50 mm×4 mm),the eluent was 10 mmol/L potassium hydroxide solution,the flow rate was 1.0 mL/min,the detector temperature was 35℃,the column temperature was 30℃,the electrical conductivity detector was adopted,the suppressor suppression current was 25 mA,and the injection volume was 25μL.Results The linear ranges of lactate ion and chloridion were 9.97-249.37μg/mL,15.27-381.70μg/mL(r=0.9997,1.0000,n=6)respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of llactate ion and chloridion were 100.74%,100.48%,with the RSDs of 1.17%,1.53%(n=9)respectively.Conclusion The established method is easy,sensitive,stable and accurate,which can be used to determine the contents of sodium lactate and total chlorine in Sodium Lactate Ringer′s Injection.

关 键 词：阴离子交换色谱法 乳酸钠 总氯 乳酸钠林格注射液 含量测定 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]