顶空气相色谱法测定聚山梨酯-80中的溶剂残留

摘要

OBJECTIVE To determine the solvent residues in polysorbate-80 by establishing headspace gas chromatog-raphy (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 fig/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.%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 DB624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6.73～1 346 μg/mL,二氯甲烷的线性范围为6.34～1 268 μg/mL,乙二醇的线性范围为3.30～660μg/mL,二甘醇的线性范围为1.87～374 μg/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 7 μg/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.