摘要
为确定购买的金刚烷胺标准品中使纯度受限的主要杂质成分,用质量平衡法对标准品中主成分含量进行定值分析。采用红外光谱、质谱等方法对金刚烷胺标准品的主成分进行定性,用气相色谱–质谱法、顶空气相色谱法、卡尔费休法对其主要杂质进行确证并定量。结果表明金刚烷胺标准品中主要杂质成分为溴代金刚烷胺、甲醇、乙苯和水,含量分别为1.53%,0.0376%,0.0045%,0.41%,经计算金刚烷胺标准品的纯度为98.16%。该方法可用于金刚烷胺标准品主要杂质的定性、定量分析,对其纯度值进行验证。
To determine the related substances which limit the purity of the amantadine standard and the massbalance method was adopted to definite the value of component content of amantadine standard. Infrared spectrum andmass spectrum method were adopted to determine the nature of the main component of amantadine standard. At the sametime,the gas chromatography–mass spectrometry,headspace gas chromatography and Karl Fischer method were appliedto identify and quantify the related substances. Ultimately,1-bromoadamantane,methanol,ethylbenzene and water werethe main impurities in amantadine standard, and the content of which were 1.53%,0.037 6%, 0.004 5% and 0.41%. Thepurity of the amantadine standard was 98.16%. This method can be used for qualitative and quantitative analysis of mainimpurities in amantadine,and verification of amantadine purity.
出处
《化学分析计量》
CAS
2015年第1期5-9,共5页
Chemical Analysis And Meterage
