顶空气相色谱法测定雌二醇/醋酸炔诺酮片中的残留溶剂  

Headspace GC Determination of Residual Solvents in Estradiol and Orethisterone Acetate Tablets

作　　者：栾成章 祝波 王亮 

机构地区：[1]山东省青岛市药品检验所,山东青岛266071

出　　处：《中国药业》2006年第6期26-27,共2页China Pharmaceuticals

摘　　要：目的建立雌二醇/醋酸炔诺酮片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,程序升温。色谱柱为6%氰丙基苯基-94%甲基聚硅氧烷(DB-624)毛细管柱,以氮气为载气,用FID检测器,测定雌二醇/醋酸炔诺酮片中异丙醇、二氯甲烷的残留量(外标法计算)。结果浓度在考察的范围内与峰面积呈良好的线性关系(异丙醇r=0.9999,二氯甲烷r=0.9995),回收率96.2%～102.1%。结论顶空气相色谱法简便,结果准确、灵敏,适用于雌二醇/醋酸炔诺酮片中异丙醇、二氯甲烷2种有机溶剂残留量的测定。Objective To establish a method for detection of two residual solvents（acetone, methanol） in estradiol and norethisterone acetate tablets. Methods The residual solvents were quantitatively determined by temperature programmed using headspace GC. The capillary column was DB-624. The carrier gas was nitrogen and FID was detector. The assay of residual solvents were calculated by external standard method. Results There was a good linearity in the experimental concentration（isopropyl alcohol r =0. 999 9, methylene chloride r =0. 999 5）. The rate of recovery was in the range of 96.2% - 102. 1%. Conclusion The method is simple, sensitive, accurate. It can used for detection of two residual solvents in estradiol and norethisterone acetate tablets.

关 键 词：顶空气相色谱法 有机溶剂残留量 雌二醇/醋酸炔诺酮片 

分 类 号：R927.11[医药卫生—药学] R977.12