顶空气相色谱法测定聚山梨酯-80中的溶剂残留  

Determination of Solvent Residues in Polysorbate-80 by Headspace Gas Chromatography

作　　者：周劼[1,2] 孙璐[1] 王晓炜[2] 杨敏[2] 刘吉金[2] 李军[2] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]深圳市药品检验所无源器械及药包材检测部,广东深圳518057

出　　处：《南京中医药大学学报》2011年第5期489-491,共3页Journal of Nanjing University of Traditional Chinese Medicine

摘　　要：目的建立顶空气相色谱法测定聚山梨酯-80中的4种溶剂残留。方法采用气相色谱法,色谱柱为Agilent DB-624毛细管柱,以正丁醇为内标定量。结果三氯甲烷的线性范围为6.73～1 346μg/mL,二氯甲烷的线性范围为6.34～1 268μg/mL,乙二醇的线性范围为3.30～660μg/mL,二甘醇的线性范围为1.87～374μg/mL。三氯甲烷、二氯甲烷、乙二醇、二甘醇残留的最低检测限分别为2.02、1.90、0.009 9、0.005 7μg/mL。结论该方法可有效的同时检测出三氯甲烷、二氯甲烷、乙二醇、二甘醇4种残留溶剂方法灵敏、准确、专属性强。OBJECTIVE To determine the solvent residues in polysorbate-80 by establishing headspace gas chromatography（HS-GC）.METHODS HS-GC with capillary column Agilent DB-624 as chromatographic column and n-butanol as the internal standard was adopted.RESULTS The linear ranges of chloroform,dichloromethane,ethylene glycol and diethylene glycol were 6.73～1 346 μg/mL,6.34～1 268 μg/mL,3.30～660 μg/mL and 1.87～374 μg/mL respectively.The detection limits of the four residual solvents were 2.02,1.90,0.009 9 and 0.005 7 μg/mL respectively.CONCLUSION This method is proved to be sensitive,accurate and specific.It can effectively determine the four solvent residues in polysorbate-80.

关 键 词：顶空气相色谱法 聚山梨酯-80 溶剂残留 

分 类 号：R284[医药卫生—中药学]