顶空气相色谱法测定硫酸氢氯吡格雷中的有机溶剂残留量  

Determination of residual organic solvents in clopidogrel bisulfate by headspace GC

作　　者：韩学静[1] 杜增辉[1] 王熳[1] 

机构地区：[1]河北省药品检验所,河北石家庄050011

出　　处：《华西药学杂志》2010年第5期587-589,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用气相色谱测定硫酸氢氯吡格雷原料药中5种有机溶剂的残留量。方法采用顶空气相色谱法,以二甲基亚砜为溶剂,用HP-1毛细管柱(50m×0.32mm,0.52μm)和FID检测器。结果 5种有机溶剂均达到了完全分离,在考察的浓度范围内具有良好线性,甲醇、异丙醇、二氯甲烷、乙酸乙酯、甲苯的最低检测浓度分别为2.2、1.7、2.0、1.9、0.7μg·mL-1,精密度的RSD均小于4.0%,平均回收率为95%～105%。样品均符合要求。结论所用方法灵敏度、准确度均达到有机溶剂残留量的检测要求,可用于硫酸氢氯吡格雷原料药中5种残留溶剂的同时检测与分析。OBJECTIVE To develop a headspace GC method for simultaneously determining the residual organic solvents methanol, isopropanol,dichloromethane,ethyl acetate and toluene in clopidogrel bisulfate. METHODS The samples were dissolved in dimethyl sulfoxide. Five organic solvents were separated on a HP-1 capillary column ( 50 m × 0. 32 mm,0. 52 μm) using programmable increased temperature. RESULTS Five residual organic solvents consisting of methanol,isopropanol,dichloromethane,ethyl acetate and toluene in clopido...

关 键 词：顶空气相色谱法 残留有机溶剂 硫酸氢氯吡格雷 

分 类 号：R927[医药卫生—药学]