摘要
建立了气相色谱-串联质谱法(GC-MS)与气相色谱法(GC)测定碘克沙醇注射液中挥发性溶剂和包材浸出物的方法。采用VF624 ms(30 m×0.25 mm,1.4μm)与DB-624(30 m×0.53 mm,3μm)色谱柱,顶空进样。在优化的色谱分离条件下,9种组分间的分离度均大于1.3。在一定浓度范围内,9种组分的峰面积与浓度均呈良好的线性关系,线性相关系数均大于0.99,平均回收率在90.2%~107.1%之间,相对标准偏差(RSD)均小于8.0%,检出限为0.001 mg/L,定量限为0.002 mg/L。方法可用于不同企业的实际样品检测,测定结果可用于评估碘克沙醇注射液与包装材料之间的相容性。
Gas chromatography-tandem mass spectrometry(GC-MS)and GC methods were established for the determination of volatile solvents and package extracts in iodixanol injection.VF624 ms(30 m×0.25 mm,1.4μm)and DB-624(30 m×0.53 mm,3μm)chromatographic columns and headspace injection were used.Under the optimum conditions,the resolution between the 9 components was greater than 1.3.The peak areas and concentrations of the 9 components showed good linear relationships within certain concentration ranges,with the correlation coefficients greater than 0.99.The average recoveries were 90.2%-107.1%,and the relative standard deviations(RSDs)were less than 8.0%.The limit of detection was 0.001 mg/L and the limit of quantification was 0.002 mg/L.This method can be applied to test actual samples in different enterprises,and the determination results can be used to evaluate the compatibility between iodixanol injection and packaging materials.
作者
薛维丽
咸瑞卿
张乃斌
巩丽萍
石峰
张迅杰
XUE Weili;XIAN Ruiqing;ZHANG Naibin;CONG Liping;SHI Feng;ZHANG Xunjie(NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Shandong Institute for Food and Drug Control,Jinan 250101,China)
出处
《分析试验室》
EI
CAS
CSCD
北大核心
2024年第10期1491-1496,共6页
Chinese Journal of Analysis Laboratory
关键词
气相色谱-串联质谱(GC-MS)
气相色谱(GC)
碘克沙醇注射液
包材浸出物
包材相容性
gas chromatography-tandem mass spectrometry(GC-MS)
gas chromatography(GC)
iodixanol in-jection
packaging material extracts
packaging material compatibility
