摘要
目的建立卡比多巴原料药中有机溶剂残留量的测定方法。方法采用顶空进样毛细管气相色谱法,色谱柱为HP-5毛细管柱(30m×0.53mm,2.65μm),载气为氮气,用FID检测器测定卡比多巴原料药中甲醇、异丙醇、三氯甲烷和甲苯的残留量(外标法计算)。结果4种有机溶剂完全分离,质量浓度在考察范围内与峰面积线性关系良好,r为0.9990～0.9996,平均回收率为94.1%～102.4%,精密度的RSD均小于10%,最低检出限为0.02～0.77μg/mL。结论顶空气相色谱法快速、灵敏、准确,可用于样品中4种有机溶剂残留量的测定。
Objective To establish a method for determining four residual organic solvents in carbidopa. Methods The residual organic solvents in carbidopa were methanol, isopropyl alcohol, dichloromethane and toluene. They were quantitatively determined by headspace GC on HP- 5 column with FID detector, nitrogen as the carries. Results Four residual solvents were completely separated. There was a good linearity in the experimental concentration （r=0. 999 0-0. 999 6）. RSD of precision was less than 10%. The average recovery rate ranged from 94. 1% to 102.4%. The detection limit was between 0.02-0. 77 μg/mL. Conclusion The method appears to be rapid, sensitive and accurate. It can be used for the determination of four residual organic solvents in carbidopa.
出处
《中国药业》
CAS
2008年第19期27-28,共2页
China Pharmaceuticals
