顶空气相色谱法测定氟孕酮中有机溶剂残留量  

Headspace GC Determination of Residual Solvents in Fluorine Progeterone

作　　者：陈爱瑛[1] 徐世芳[1] 姜丽霞[1] 

机构地区：[1]浙江省医学科学院药物研究所,杭州310013

出　　处：《中国现代应用药学》2008年第z2期721-723,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 建立顶空气相色谱法测定氟孕酮中4种有机溶剂残留量的方法.方法 采用顶空气相色谱法,FID检测器, DB-624( 6%氰丙基苯基-94%二甲基聚硅氧烷)毛细管柱(30 m×0.53 mm×3 μm).程序升温,载气为氮气,进样口温度150 ℃ ,检测器温度260 ℃ .结果 4种有机溶剂完全分离,在所考察的浓度范围内具有良好线性,甲醇、乙醇、丙酮、醋酸乙酯检测限分别为0.06,0.50,0.25,0.50 μg·mL-1,精密度RSD均小于5.0% ,平均回收率为98% ～104% .结论 经方法学验证,本试验建立的方法简便灵敏,结果准确可靠,适用于氟孕酮原料药中有机溶剂残留量的检测.OBJECTIVE To establish a method for determining the residues of four kinds of solvents in Fluorine Progeterone by headspace gas chromatography.METHODS The detector was FID.The analytical column was DB-624(30 m×0.53 mm×3 μm).The injector temperature was 150 ℃,and the detector temperature was 260 ℃. RESULTS It appears a good linearity in the experimental concentration.The detector limit of methanol,ethanol,Acetone,vinyl acetate separately was 0.06,0.50,0.25,0.50 μg·mL-1.The RSD of precision and were all less than 5.0%.The average recovery was 98%-104%.CONCLUSION This method is simple,sensitive,accurate,is can be used for detection of four residual solvents in Fluorine Progeterone.

关 键 词：氟孕酮 有机溶剂残留量 顶空气相色谱法 

分 类 号：R917.101[医药卫生—药物分析学] R927.12[医药卫生—药学]