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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=0.999 9),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。
To establish a method for the determination of 5 organic solvents residues in ethanol, tetrahydrofuran, isopropyl ether, ethyl acetate and butanone by gas chromatography in the sarpogrelate hydrochloride production process. With the special column of AT.LZP-930 and flame ionization detector (FID), all five kinds of organic solvents can be well separated, and the solvent has no influence on the determination. Within the range of test concentration, the peak area has a good linear relationship with the concentration (R2 = 0.999 9). The RSDs of injection precision test were less than 3.0%. The detection limits of ethanol, tetrahydrofuran, isopropyl ether, ethyl acetate and methyl ethyl ketone were 1.95, 2.83, 0.95, 1.43, 2.68 mg / kg, the recovery rate of 90% to 103%. The method is simple, accurate, sensitive and reproducible. It can be used for the determination of sarpogrelate hydrochloride organic solvents.