CAJ | 학술논문

建立气相色谱法测定盐酸沙格雷酯生产工艺中，乙醇、四氢呋喃、异丙醚、乙酸乙酯、丁酮5种有机溶剂残留的方法。采用AT.LZP-930型分析专用柱和火焰离子化检测仪（FID），5种有机溶剂均能得到良好的分离，溶剂对测定无影响，在测试浓度范围内，峰面积与浓度线性关系良好（R2=0.9999），进样精密度试验的RSD值均小于3.0%，乙醇、四氢呋喃、异丙醚、乙酸乙酯和丁酮最低检测限分别为1.95，2.83，0.95，1.43，2.68 mg/kg，回收率90%~103%。该方法简单、准确、灵敏度高且重现性好，可用于盐酸沙格雷酯有机溶剂残留的测定。
건립기상색보법측정염산사격뢰지생산공예중，을순、사경부남、이병미、을산을지、정동5충유궤용제잔류적방법。채용AT.LZP-930형분석전용주화화염리자화검측의（FID），5충유궤용제균능득도량호적분리，용제대측정무영향，재측시농도범위내，봉면적여농도선성관계량호（R2=0.9999），진양정밀도시험적RSD치균소우3.0%，을순、사경부남、이병미、을산을지화정동최저검측한분별위1.95，2.83，0.95，1.43，2.68 mg/kg，회수솔90%~103%。해방법간단、준학、령민도고차중현성호，가용우염산사격뢰지유궤용제잔류적측정。
Levels of ethanol, tetrahydrofuran, isopropyl ether, ethyl acetate and butanone residual solvents are evaluated in sarpogrelaogrelate hydrochloride by Gas Chromatography. The AT.LZP-930 of liquor analysis dedicated capillary column and flame ionized detector (FID) is used to determine residual solvent levels and 5 organic solvents can be well separated, the solvent has no effect on the determination. The peak area and concentration linear relationship is good (R2=0.999 9) , RSD less than 3.0% in the test concentration range. The LOD of ethanol, tetrahydrofuran, isopropyl ether, ethyl acetate and butanone are 1.95, 2.83, 0.95, 1.43, 2.68 mg/kg, respectively. The range of recoveries is 90%~103%. This method is simple, accurate, high sensitivity, good reproducibility and might be used for the determination of residual organic solvent of the drug.