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-1。结论:该法快速、简便,适用于原料的质量控制。
Objective： To establish a capillary gas chromatography method for the determination of residual organic solvents in pitavastatin calcium.Methods： Simple capillary column injection method was 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 RSD were 0.6%-1.0%,the detection limits were 0.1-0.5μg·ml^-1.Conclusion： This method is fast and accurate,and is suitable to the material quality control.
出处
《现代医学》
2013年第2期119-121,共3页
Modern Medical Journal
关键词
匹伐他汀钙
有机溶剂残留量
气相色谱
pitavastatin calcium
residual organic solvent
capillary gas chromatography
