氯化钠注射液中抗氧剂及其降解产物迁移量的测定  

Determination of the migration of antioxidant and their degradation products in sodium chloride injection

作　　者：蔡心怡 刘言 CAI Xinyi;LIU Yan(Tianjin Institute of Drug Control,Tianjin 300070,China)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《天津药学》2025年第2期129-132,共4页Tianjin Pharmacy

摘　　要：目的 建立氯化钠注射液中抗氧剂1010、330、1076、168及其降解产物抗氧剂1310、2,4-二叔丁基苯酚含量的高效液相色谱(HPLC)测定方法,考察包材中抗氧剂及其降解产物向药液的迁移情况。方法 色谱柱为Diamonsil C18(250 mm×4.6 mm, 5μm),流动相为0.5%醋酸水溶液-四氢呋喃-乙腈(梯度洗脱),检测波长274 nm。通过固相萃取试验,对6批氯化钠注射液中的抗氧剂1010、330、1076、168及其降解产物抗氧剂1310、2,4-二叔丁基苯酚迁移量进行测定。结果 抗氧剂1010、330、1076、168、1310及2,4-二叔丁基苯酚分别在1.0~100.8、1.0~98.6、2.0~200.1、2.0~196.4、1.0~98.6及0.5~54.6μg/mL呈良好的线性关系;平均回收率在92.26%~95.41%,相对标准偏差(RSD)值在1.43%~3.51%。其中3批样品5个时间点未检测出迁移的抗氧剂,另3批样品5个时间点检测出抗氧剂降解产物1310,迁移量为0.06~0.43μg/mL。结论 该方法便捷、准确、灵敏,可以准确测定氯化钠注射液中的抗氧剂及其降解产物。Objective To establish an High Performance Liquid Chromatography(HPLC)method for the determination of the contents of antioxidants 1010,330,1076,168 and their degradation products,antioxidant 1310 and 2,4-di-tert-butylphenol in sodium chloride injection,and study the migration of antioxidants and their degradation products from plastic packaging materials to sodium chloride injection.Methods The chromatographic column was Diamonsil C18(250 mmx4.6 mm,5μm).0.5%acetic acid aqueous solution-tetrahydrofuran-acetonitrile were as mobile phase with a gradient mode.The ultraviolet detection wave length was set at 274 nm.Through solid-phase extraction experiments,the migration amounts of antioxidants 1010,330,1076,168 and their degradation products,antioxidant 1310 and 2,4-di-tert-butylphenol in 6 batches of sodium chloride injection were measured.Results Antioxidants 1010,330,1076,168,1310 and 2,4-di-tert-butylphenol showed good linearity in the concentration range of 1.0~100.8,1.0~98.6,2.0~200.1,2.0~196.4,1.0~98.6 and 0.5~54.6μg/mL,respectively.The average recovery rate was 92.26%~95.41%,and the relative standard deviation was 1.43%~3.51%.No migrated antioxidants were detected at five time points in 3 batches of samples,while the antioxidant degradation product 1310 was detected at five time points in the other 3 batches of samples,with the migration a-mount ranging from 0.06 to 0.43μg/mL.Conclusion This method is convenient,accurate and sensitive,and can accurately determine the antioxidants and their degradation products in sodium chloride injection.

关 键 词：高效液相色谱法 氯化钠注射液 抗氧剂 降解产物 迁移量 药包材相容性 

分 类 号：R927.11[医药卫生—药学]