气相色谱法测定对乙酰氨基酚片中的残留溶剂乙醇的含量  

Determination of Residual Solvents in Acetaminophen TabletsbyGC:Content of Ethanol

作　　者：肖艳 高永坚 梁标志 区淑蕴 XIAO Yan;GAO Yong-jian;LIANG Biao-zhi;OU Shu-yun(Sinopharm Group Guangdong Medi-World Pharmaceutical Co.,Ltd.,Guangdong Foshan 528300,China)

机构地区：[1]国药集团广东环球制药有限公司,广东佛山528300

出　　处：《广州化工》2024年第6期147-150,共4页GuangZhou Chemical Industry

摘　　要：建立气相色谱法检测对乙酰氨基酚片中残留溶剂乙醇的含量。采用5%苯基甲基聚硅氧烷(DB-5)色谱柱,氢火焰离子化(FID)检测器,程序升温。方法的线性范围为0.0008~1.0020 mg/mL(R^(2)=0.9999);回收率为92.55%~102.01%,RSD为2.93%;精密度RSD为3.87%;检测限为0.2386μg;定量限为0.7952μg。该方法简单快速、专属性好,结果准确可靠、重现性好、灵敏度高,可用于对乙酰氨基酚片中残留溶剂乙醇的含量测定。To establish a gas chromatography method for determination of residual solvent ethanol in Acetaminophen Tablets.Using acapillary column(DB-5)containing 5%phenyl methyl polysiloxane.Using a hydrogen flame ionization detector(FID),program temperature.The linear range of the method was 0.0008~1.0020 mg/mL(R^(2)=0.9999),the recovery was 92.55%~102.01%,RSD=2.93%,Precision 3.87%RSD,The DOQ was 0.2386μg,The LOQ was 0.7952μg.The method was simple,specific,accurate,reliable and reproducible.It can be used to determine the ethanol content in Acetaminophen Tablets.

关 键 词：对乙酰氨基酚片 残留溶剂 乙醇含量 气相色谱法 

分 类 号：R914.1[医药卫生—药物化学]