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毛细管气相色谱法测定匹伐他汀钙中5种有机溶剂残留量
作者:单国冰 宋祥珍 李纬  
单位:南京市下关医院
关键词:匹伐他汀钙 有机溶剂残留量 气相色谱法 
分类号:
出版年·卷·期(页码):2013·41·第二期(119-121)
摘要:

目的:建立匹伐他汀钙中有机溶剂残留量的气相色谱测定法。方法:采用毛细管气相色谱进样法,以DMF为溶剂,甲苯为内标,测定匹伐他汀钙中5种有机溶剂甲醇、乙醇、二氯甲烷、正己烷和四氢呋喃的残留量。结果:5种有机溶剂的线性关系良好(R>0.999);平均回收率为100.0% ~102.2%,RSD为0.6%~ 1.0%,最低检测量为0.1~0.5μg/mL。结论:该法快速、简便,适用原料的质量控制。

Objective To establish a GC Method for the determination of residual organic solvents in Pitavastatin Calcium. Method A simple capillary column injection method used for the determination of residual methanol, ethanol, dichlormethane, N-hexane and tetrahydrofuran, in Pitavastatin Calcium. Results The linearities were good, the average recoveries were 100.0% ~102.2%, and RSD0.6%~ 1.0%, the detection limits were 0.1~0.5μg/mL. Conclusion This method is fast and accurate, and is suitable to the material quality contro1.

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