GC与GC-MS测定十二烷基硫酸钠纯度与含量.pdfVIP

GC/GC-MS测定十二烷基硫酸钠纯度与含量 1* 2 2 刘建祯 ，程奇蕾，张启明 （1. 山西省药品检验所，太原030001；2. 中国药品生物制品检定所，北京100050） 摘要 目的：研究十二烷基硫酸钠的质量问题。方法：采用HP-5 （30 m× 0.53 mm ，1.50 μm） 毛细管柱，以氮气为载气，FID 检测，程序升温，直接进样，采用面积归一化法测定十二烷基 硫酸钠水解产物十二烷醇的气相纯度，外标法以十二烷醇为对照品测定十二烷基硫酸钠的含量。 -1 -1 结果：十二烷醇在6.16 μgmL ～6.16 mg·m 的浓度范围内具有良好的线性关系，相关系数为 0.9999 。不同企业的相同标示含量的产品纯度存在较大差异。结论：本方法简便，结果准确， 重现性好，可用于十二烷基硫酸钠气相纯度和含量的测定。 关键词：GC ；GC-MS ；十二烷基硫酸钠；毛细管柱；气相纯度；含量测定 Quality control research of SDS 1,2 1 3 1* LIU Jian-zhen ，CHENG Qi-lei ，HANG Tai-jun ，ZHANG Qi-ming （1 . National Institute for the Control of Pharmaceutical and Biological Products , Beijing 100050 , China； 2 . Shanxi Institute for Drug Control , Taiyuan 030001 ,China； 3.Department of Pharmaceutical Analysis，China Pharmaceutical University，Nanjing 210009 ，China ） Abstract Objective ：To research quality problem of SDS by capillary gas chromatography. Method ：The capillary column was HP-5（30 m×0.53 mm，1.50 μm）.The carrier gas was nitrogen and FID as detector，temperature programming and direct sample injection. To determine impurity of 1-Dodecanol which is hydrolysate of SDS by peak area normalization, to determine content of SDS by external standard method in which 1-Dodecanol is reference substance. Results ：Under the above -1 condition，there was good linear relationship in the concentration range of 6.16 μgmL ～6.16 mg·m -1 ，r=0.9999. There were relatively great differences in impurity over products of different manufacturers