顶空气相色谱法测定盐酸左布比卡因中残留溶剂

目的:建立盐酸左布比卡因原料药中有机溶剂残留量的测定方法.方法:采用内标法项空进样毛细管气相色谱法,测定盐酸左布比卡因原料中有机溶剂残留量.色谱柱为DB - 624毛细管柱(30m×0.53mm,3.0μm),载气为氮气,FID检测器；程序升温,在60℃下保留5min,然后以20℃/min的速率升温至200℃,保持10min；进样口温度220℃,检测器温度240℃,分流比为1∶1.结果:质量浓度在范围内与峰面积线性关系良好,r为0.999 98,平均回收率为103.2％,精密度的RSD为0033％,最低栓出限为0.14μg/mL.结论:该方法可用于盐酸左布比卡因中有机溶剂残留量的测定.

Determination of Residual Organic Solvents in Levobupivacaine Hydrochloride by Headspace GC

Objective:To establish a method for determining organic residual solvents in Levobupivacaine Hydrochloride.Methods:The headspace-capillary gas chromatography with internal standard method was used.The separation was performed on a DB-624 capillary column(30m×0.53mm,3.0μm)with nitrogen as carrier gas and FID detector.The column temperature was initially maintained at 60℃ for 3min,then increased to 200℃(20℃·min-1)and maintained for 5 min.The injection port temperature was 220℃ and the detector temperature was 240℃.The split ratio was 1:1.Results:There was a good linearity in the experimental concentration(r=0.999 98)RSD of precison was 0.4%.The average recovery rate ranged was 103.2%.The detection limit was 0.14μg/mL.Conclusion:The method can be used to determine the residual solvents in Levobupivacaine Hydrochloride.