CAJ | 학술논문

目的：建立采用顶空进样-毛细管气相色谱法对第3代治疗糖尿病药物磺酰脲类降糖药格列美脲原料药中正己烷、丙酮、二氯甲烷、甲醇和甲苯5种有机溶剂的残留量测定方法，为格列美脲原料药中5种有机溶剂的残留量提供科学检测方法。方法：采用顶空进样程序升温法，平衡温度为110℃，FID检测器，DM-5毛细管色谱柱（30m ×03．2mm ，02．5μm）进行检测。结果：5种有机溶剂在各自浓度范围线性关系良好（r＝09．958～0．9991，n＝5），最低检测限为05．8～11．8μg·ml -1；定量限范围为1．9～47．3μg· ml -1；3个浓度的平均回收率为951．％～1035．％，（RSD＝10．％～51．％，n＝6）。结论：该方法灵敏简单、科学严谨、可操作性强、结果可靠，可用于实际生产格列美脲原料药中5种溶剂残留的测定分析。
목적：건립채용정공진양-모세관기상색보법대제3대치료당뇨병약물광선뇨류강당약격렬미뇨원료약중정기완、병동、이록갑완、갑순화갑분5충유궤용제적잔류량측정방법，위격렬미뇨원료약중5충유궤용제적잔류량제공과학검측방법。방법：채용정공진양정서승온법，평형온도위110℃，FID검측기，DM-5모세관색보주（30m ×03．2mm ，02．5μm）진행검측。결과：5충유궤용제재각자농도범위선성관계량호（r＝09．958～0．9991，n＝5），최저검측한위05．8～11．8μg·ml -1；정량한범위위1．9～47．3μg· ml -1；3개농도적평균회수솔위951．％～1035．％，（RSD＝10．％～51．％，n＝6）。결론：해방법령민간단、과학엄근、가조작성강、결과가고，가용우실제생산격렬미뇨원료약중5충용제잔류적측정분석。
Objective:To develop the headspace capillary gas chromatography method for the determina-tion of residual organic solvents consisted of methanol ,acetone ,dichloromethane ,n-hexane and toluene in Glimepiride .Methods:The samples were injected by headspace sampler with program heating and FID detec-tor .The determination was performed on DM-5 GC capillary column(30m × 0 3.2mm ,0 2.5μm) .Results :Line-ar response were obtained for methanol ,acetone ,dichloromethane ,n-hexane and toluene in their respective concentration ranges (r=0 9.958-0 9.991 ,n=5) ,and the limits of detection were 0 5.8~11 8.μg · ml-1 ,the limits of quantity were 1 9.~47 3.μg · m -1 .The average recoveries of three concentration levels were 95 1.% ~103 5.% ,with RSD=1 0.% ~5 1.% (n=6) .Conclusion:The developed method is simple ,sensitive ,and accu-rate .It can be used for the detection of the residual solvents in glimepiride .