甲磺酸瑞波西汀中有机溶剂残留量的毛细管气相色谱测定

Determination of Residual Organic Solvents in Reboxetine Mesylate by Capillary GC

采用毛细管气相色谱法,测定甲磺酸瑞波西汀中有机溶剂乙醇、二氯甲烷、叔丁醇、异丙醚、乙酸乙酯、二噁烷、吡啶和甲苯的残留量。用DB-624(0.53mm×75m×3.0mm)毛细管色谱柱,柱温采取程序升温法。各溶剂的线性良好(r均大于0.99),平均回收率86.6%～106.6%,检测限0.092～1.6mg/ml。

A simple capillary GC method for the determination of residual organic solvents(ethanol, dichloromethane,t-butanol, isopropyl ether, ethyl acetate, 1,4-dioxane, pyridine and toluene) in reboxetine masylate was established. A DB-624 capillary column was used with procedural column temperature control. The calibration curves were linear(r>0.99).The average recoveries were 86.6%～106.6%. The detection limites were 0.092～1.6mg/ml.