毛细管色谱法测定唑尼沙胺中的有机溶剂残留量

Determination of residual organic solvents in zonisamide by capillary gas chromatography

目的建立毛细管气相色谱法测定唑尼沙胺中的有机溶剂残留量。方法用DB-624毛细管气相色谱柱，FID检测器，以正丙醇为内标进行测定。结果甲醇、乙醇、乙酸乙酯、乙酸的线性范围分别为15．029～240．464mg·L^-1（r=0.9999）、24．964～399．424mg·L^-1（r=1）、25．02～400，32mg·L^-1（r=0.9999）、24.99～399.84mg·L^-1（r=0．9999）；甲醇、乙醇、乙酸乙酯、乙酸的平均回收率分别为99．5％、99．0％、98.9％、99.2％；RSD分别为1.2％、1．4％、1．2％、1．5％1（n=9）。结论方法简单、灵敏、准确、重现性好，适用于唑尼沙胺中的有机溶剂残留量的测定。

Objective To develop a gas chromatography method for the determination of residual organic solvents in zonisamid. Methods The samples were injected into DB-624 capillary column and analyzed with FID detector using n-propyl alcohol as the internal standard. Results The linear ranges of methanol, ethanol, ethyl acetate, acetic acid were 15. 029 - 240. 464 mg·L^-1 （ r = 0. 999 9）, 24. 964 - 399. 424 mg·L^-1（ r = 1 ）, 25.02 - 400.32 mg·L^-1（ r = 0. 999 9）, 24.99 - 399.84 mg·L^-1（ r = 0. 999 9）, respectively. The recoveries were 99.5%,99.0%,98.9%,99.2% ;RSD were 1.2%, 1.4%, 1.2%, 1.5% （n =9）, respectively. Conclusions The method is simple, accurate and sensitive with good reproducibility. It can be used for the determination of the residual organic solvents in zonisamide.