摘要
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:采用内标法顶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0.99998,平均回收率为103.2%,精密度的RSD为0.33%,最低检出限为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。
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.
出处
《黑龙江医药》
CAS
2012年第4期521-522,共2页
Heilongjiang Medicine journal
