摘要
本文采用C18固相萃取柱富集,甲醇和水为流动相进行等度洗脱,并以外标法定量,建立了对乙酰氨基酚注射液及复方氨基酸（15）双肽（2）注射液中抗氧剂BHT的固相萃取高效液相色谱测定新方法。实验结果表明,新方法检测抗氧剂BHT在0.2182~10.91μg/m L范围内线性关系良好,相关系数0.9999,定量限为0.2182μg/m L,对乙酰氨基酚注射液加标回收率为76.75%~91.95%,复方氨基酸（15）双肽（2）注射液加标回收率为106.37%~110.03%,RSD小于等于6.00%。新方法更准确、简单、灵敏、可靠,适用于对乙酰氨基酚注射液、复方氨基酸（15）双肽（2）注射液等极性较大注射剂中抗氧剂BHT的限量及定量检测。
A new method of solid phase extraction coupled with high performance liquid chromatography（SPE-HPLC） was developed for the determination of antioxidant BHT in paracetamol injection and amino acids（15） and dipeptides（2） injection. The samples were concentrated by C18 SPE cartridge. The antioxidant BHT were separated using methanol and water as mobile phases. The external matrix standard solutions were used for the quantitative determination. The antioxidant BHT showed good linearity in the range of 0.2182~10.91 μg/m L with the correlation coefficients 0.9999. The limits of quantification（LOQ） was 0.2182 μg/m L. The spiked recoveries of paracetamol injection ranged from76.75% to 91.95%, and amino acids（15） and dipeptides（2） injection 106.37%~110.03%. The relative standard deviations were less than or equal to 6.00%.
出处
《中国医疗器械信息》
2015年第12期52-56,共5页
China Medical Device Information
作者简介
曲亚南，工程师
