气相色谱法测定高级脂肪醇中的有关物质

Determination of Related Substances in Higher Fatty Alcohol by GC

研究建立了测定高级脂肪醇中有关物质的方法。采用气相色谱法,色谱柱为DB-225型毛细管柱(30 m×0.25 mm×0.25μm),设置程序升温,使用氢火焰离子化检测器(FID)进行测定。研究考察的十六烷、十八烷、十二醇、十四醇、十五醇、十六醇、十八醇、油醇、次亚麻醇、二十醇10种组分具有较好的分离度,质量浓度在0.5~100μg·ml^(-1)范围内线性关系良好,灵敏度高,精密度与溶液稳定性RSD均小于2.0%,各组分回收率为96.56%~101.76%。该方法快速准确,可有效分离与测定高级脂肪醇中常见的10种有关物质。对市售的药用辅料产品进行了考察,结果表明,24批样品中均不含油醇,已知单杂均低于1.0%,未知杂质总量不超过1.0%;杂质总量不超过2.0%。

A gas chromatography method was established to determine the related substances of higher fatty alcohol.The DB-225 capillary column(30 m×0.25 mm×0.25μm)was used.The programmed column temperature and FID detector was adopted.The results showed that ten components of hexadecane,octadecane,dodecanol,tetradecanol,pentadecanol,cetyl alcohol,stearyl alcohol,oleyl alcohol,linolenyl alcohol and icosanol could be effectively separated.It was linear for all of them in the range of 0.5~100μg·ml^(-1).The RSDs of precision and stability were less than 2.0%,and the recoveries was 96.56%~101.76%.The method is rapid and accurate,and can effectively separate and determinate 10 common related substances in higher fatty alcohols.The commercial pharmaceutical excipients were investigated.The results of the 24 samples showed that no oleyl alcohol involved,the any identified impurities were all less than 1.0%,the sum of unidentified impurities were less than 1.0%,and the sum of impurities were less than 2.0%.