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目的::建立毛细管气相色谱法测定酒石酸托特罗定中8种有机溶剂残留量的方法。方法:采用CP-sil 5CB色谱柱(60.0 m ×0.32 mm,5μm);进样口温度为200℃;FID检测器温度为250℃;载气流速为1.2 ml·min-1;柱温120℃;顶空瓶平衡温度85℃,时间30 min,以二甲基甲酰胺-水(1∶4)混合溶液为溶解介质,测定酒石酸托特罗定中甲醇,乙醇,乙腈,丙酮,乙酸乙酯,三氯甲烷和四氢呋喃的残留量;采用HP-1色谱柱(30.0 m ×0.53 mm,5μm),进样口温度为220℃;FID检测器温度为250℃;载气流速为3.0 ml·min-1;柱温80℃;顶空瓶平衡温度85℃,时间30 min,以二甲亚砜-氢氧化钠溶液(17∶13)混合溶液为溶解介质,测定酒石酸托特罗定中吡啶的残留量。结果:在各色谱条件下,被测溶剂峰之间均分离良好,8种溶剂的标准曲线线性良好,相关系数均大于0.999;平均回收率为86.0%~100.2%,RSD为1.7%~3.5%(n=9);甲醇,乙醇,乙腈,丙酮,乙酸乙酯,三氯甲烷,四氢呋喃和吡啶的检测限分别为0.63,0.43,0.30,0.18,0.079,0.36,0.18,0.89μg·ml-1。结论:该法适用于酒石酸托特罗定中这8种有机溶剂残留量的测定。“,”Objective:To establish a method for the determination of 8 residual organic solvents in tolterodine tartrate by capillary GC. Methods: The determination of methanol, ethanol, acetonitrile, acetone, ethyl acetate, trichloromethane and tetrahydrofuran in tolterodine tartrate dissolved in the solution of N, N-dimethylformamide-water ( 1∶ 4 ) was carried out on a CP-sil 5CB ( 60. 0 m × 0. 32 mm,5μm)column. The inlet temperature was 200℃ and the FID detector temperature was 250℃. The flow rate of carrier gas was 1. 2 ml·min-1 . The column temperature was 120℃. The headspace vial temperature was 85℃ and the time was 30min. The determina-tion of pyridine in tolterodine tartrate dissolved in the solution of dimethylsulfoxide-sodium hydroxide (17∶13) was carried out on an HP-1(30. 0 m × 0. 53 mm,5 μm) column. The inlet temperature was 220℃ and the FID detector temperature was 250℃. The column tem-perature was 80℃. The flow rate of carrier gas was 3. 0 ml·min-1 . The headspace vial temperature was 85℃ and the time was 30 min. Results:All peaks could be separated from each other under the chromatographic conditions. The linearity of the eight solvents was falrly good (r>0. 999). The average recovery was ranged from 86. 0% to 100. 2% with RSD of 1. 7%-3. 5% (n=9). The limit of detection was 0. 63, 0. 43, 0. 30, 0. 18, 0. 079, 0. 36, 0. 18 and 0. 89 μg·ml-1 , respectively. Conclusion:The methods can be applied in the determination of the eight residual organic solvents in tolterodine tartrate.