顶空气相色谱法测定生脉注射液中甲醛和乙醛的含量  

Determination of Formaldehyde and Acetaldehyde in Shengmai Injection by Headspace Gas Chromatography

作　　者：金伟斌 陈礼峰 唐倩倩 顾晓风 JIN Wei-bin;CHEN Li-feng;TANGQian-qian;GU Xiao-feng(Suzhou Institute for Drug Control,Suzhou 215104,China;Shandong Lvye Pharmaceutical Co.,Ltd,Yantai 264670,China)

机构地区：[1]苏州市药品检验检测研究中心,苏州215104 [2]山东绿叶制药有限公司,烟台264670

出　　处：《中国合理用药探索》2022年第6期115-120,共6页Chinese Journal of Rational Drug Use

摘　　要：目的:基于顶空气相色谱法建立生脉注射液中甲醛和乙醛的含量测定方法。方法:采用Agilent HP-INNOWAX毛细管色谱柱(30m×0.32mm,0.5μm),程序升温,进样口温度为200℃,氢火焰离子化检测器(FID)温度为250℃,流速为1.0ml/min,分流比为10∶1,顶空进样平衡温度为80℃,平衡时间20min,进样时间1min。结果:甲醛在0.10~2.00μg/ml范围内线性关系良好(r=0.9996),乙醛在0.24~4.82μg/ml范围内线性关系良好(r=0.9995)。平均加样回收率分别为101.4%和94.1%,RSD分别为1.09%和0.95%。6批样品甲醛含量在0.26~1.28μg/ml范围内,乙醛含量在1.52~3.59μg/ml范围内。结论:该方法操作简单,灵敏度高,准确度高,可用于生脉注射液中甲醛和乙醛含量的控制。Objective:To establish a method for the quantitative determination of formaldehyde and acetaldehyde in Shengmai injection based on headspace gas chromatography.Methods:Agilent HPINNOWAX capillary column(30 m×0.32 mm,0.5μm)was selected.The column temperature was programmed.The inlet temperature was 200℃ and flame ionization detector(FID)temperature was 250℃.The flow rate was 1.0 ml/min and split ratio was 10∶1.The equilibrium temperature of headspace injection was 80℃,the equilibrium time was 20 min and the injection time was 1 min.Results:The calibration curve of formaldehyde was linear in the range of 0.10~2.00μg/ml(r=0.9996)and the acetaldehyde was linear in the range of 0.24~4.82μg/ml(r=0.9995).The average recoveries were 101.4% and 94.1%,respectively;RSD was 1.09% and 0.95%,respectively.The content of formaldehyde in 6 batches was within the range of 0.26~1.28μg/ml and the content of acetaldehyde in 6 batches was within the range of 1.52~3.59μg/ml.Conclusion:The method developed is easy,sensitive and accurate,and it can be used for the content control of formaldehyde and acetaldehyde in Shengmai injection.

关 键 词：生脉注射液 聚山梨酯80 甲醛 乙醛 顶空气相色谱法 

分 类 号：R286.0[医药卫生—中药学]