电感耦合等离子体质谱法测定盐酸左氧氟沙星氯化钠注射液中24种元素杂质的含量  

Content determination of 24 element impurities by ICP-MS in levofloxacin hydrochloride and sodium chloride injection

作　　者：赵冯 张杞柳 张石楠 陈辉 ZHAO Feng;ZHANG Qi-liu;ZHANG Shi-nan;CHEN Hui(Xuzhou Inspection Testing Center,Xuzhou Jiangsu 221000)

机构地区：[1]徐州市检验检测中心,江苏徐州221000

出　　处：《中南药学》2023年第7期1921-1925,共5页Central South Pharmacy

基　　金：江苏省市场监督管理局科技计划项目(No.KJ21125019)。

摘　　要：目的建立电感耦合等离子体质谱(ICP-MS)法同时测定盐酸左氧氟沙星氯化钠注射液中24种元素杂质的含量。方法样品直接稀释后分析,内标元素为钪(45),铟(115),铋(209)。内标液添加5%异丙醇进行基质匹配。射频功率1550 W,He气模式,雾化气流量0.7 L·min^(-1),补偿气流量0.3 L·min^(-1)。结果24种元素在各自的检测浓度范围内线性关系良好(r>0.999)。检测限为0.00004~0.04 ng·mL^(-1),加标回收率为77%~113%,重复性RSD在1.0%~6.8%,中间精密度RSD在1.3%~7.9%。不同厂家的盐酸左氧氟沙星氯化钠注射液中的24种元素杂质含量均符合人用药品技术要求国际协调理事会(ICH)的相关规定。结论本实验建立的检测方法简便快速,准确灵敏,可用于盐酸左氧氟沙星注射液中元素杂质的质量控制。Objective To simultaneously determine 24 impurities in levofloxacin hydrochloride and sodium chloride injection by inductively coupled plasma mass spectroscopy(ICP-MS).Methods Samples were analyzed after direct dilution.Sc(45),In(115)and Bi(209)were used as the internal standard.The internal standard solution was supplemented with 5%isopropanol for matrix matching.Radio frequency power was set at 1550 W,He gas mode,and the nebulizer gas flow was set at 0.7 L·min^(-1),and make up gas flow was set at 0.3 L·min^(-1).Results The 24 elements showed good linearity in the specified concentration range with all the correlation coefficients(r)above 0.999.The detection limits ranged 0.00004~0.04 ng·mL^(-1),the recoveries ranged 77%~113%,and the repeatability and intermediate precision ranged 1.0%~6.8%and 1.3%~7.9%,respectively.The content of 24 elemental impurities in levofloxacin hydrochloride and sodium chloride injection from different manufacturers met the ICH requirements.Conclusion The established method is simple,rapid,accurate,and sensitive,and suitable for the impurity control in levofloxacin hydrochloride and sodium chloride injection.

关 键 词：盐酸左氧氟沙星氯化钠注射液 ICP-MS ICH Q3D 元素杂质 基质匹配 

分 类 号：R917[医药卫生—药物分析学]