气相色谱法测定甲磺酸罗哌卡因中有机溶剂残留量

Determination of the residual organic volatile solvents in ropivacaine mesylate by GC

目的：测定甲磺酸罗哌卡因中残留有机溶剂乙醇、丙酮和甲苯的含量。方法：采用气相色谱法，氢火焰离子化检测器，以水为溶剂，乙酸乙酯为内标，在5％苯基-95％二甲基聚硅氧烷（0．53mm×30m，5μm）毛细管色谱柱上，柱温50℃保持4min，10℃／min升温至100℃，保持2min，各组分达到基线分离。结果：乙醇、丙酮和甲苯的线性范围分别为50～800、50～800和8．9～142μg／ml，相关系数（r）分别为0．9986．0．9998和0．9967，平均回收率分别为102．0％、104．0％和98．4％（n=9）。结论：本方法简便、灵敏度高、结果准确，适用于甲磺酸罗哌卡因中有机溶剂残留量的测定。

Objective： To determine the residual organic volatile solvents（ ethyl alcohol, acetone and toluene） in ropivacaine mesylate by GC. Methods： The sample in water was analyzed by a 5% phenyl -95 % dimethylpolysiloxane capillary column （0.53 mm ×30 m,5μm） with FID. The column temperature was 50 ℃ for 4 min, then was raised to 100℃ by the rate of 10 ℃/min and sustained 2 min. Every organic residue and the ethyl acetate, an internal standard, were separated thoroughly with each other. Results ： The linear range of ethyl alcohol、acetone and toluene were 50 - 800 μg/ml （ r = 0. 998 6 ）, 50 - 800 μg/ml （ r = 0. 999 8） and 8.9 - 142μg,/ml （r =0.996 7） respectively; the recovery was 102.0%, 104.0% and 98.4% respectively. Conclusion： This method is sensitive,accurate and easy to be operated,and can be used for the determination of the residual organic volatile solvents in ropivacaine mesylate.