气相色谱法测定核苷类药物中的有机溶剂残留量

Determination of Residual Organic Solvents in Nucleoside Medications by Capillary Gas Chromatography

摘要: 用HP-5毛细管气相色谱柱、FID检测器,以二甲亚砜为溶剂进行外标法定量测定药物合成产物中的有机溶剂残留量.乙腈、乙酸乙酯的线性范围分别为0.787~15.700μg(R²=0.9994)、0.180~4.510 mg(R²=0.9991),回收率测试结果满足分析测试的要求,最低检测限分别为3.9、0.40 mg/mL.本方法简单、准确、灵敏高,重现性好,适用于核苷类药物中有机溶剂残留量的测定.

Abstract: The samples were injected into HP-5 caplillary column and analyzed with FID detector.Dimethyl sulfoxide was used as solvents,the external standard(ESTD) calculation.The linear ranges of acetonitrile and ethyl acetate,were 0.787~15.700 μg(R²=0.9994) and 0.180~4.510 g(R²=0.9991) respectively;and the results of recovery tests were satisfying;the detection limits were 3.9,0.40 g/mL respectively.The method was simple,accurate and sensitive with good reproducibility.It can be used for the determination of the residual organic solvents in nucleoside medications.