GC柱前衍生化法测定片剂样品中辅料硬脂酸镁的含量  

Determination of Magnesium Stearate in Tablets by GC Precolumn Derivatization

作　　者：单文俊 李建波 周君安 何雷 Shan Wenjun;Li Jianbo;Zhou Jun′an;He Lei(Jiangsu Hansoh Pharmaceutical Group Co.,Ltd.,Lianyungang 222000,China)

机构地区：[1]江苏豪森药业集团有限公司,江苏连云港222000

出　　处：《山东化工》2021年第19期149-150,155,共3页Shandong Chemical Industry

摘　　要：目的:测定片剂药品中硬脂酸镁的含量。方法:采用气相色谱法,用DB-WAX毛细管色谱柱;FID检测器;进样口温度为220℃;检测器温度为260℃;柱初始温度为70℃,维持2 min,以每分钟10℃的速率升温至230℃,维持8 min。结果:该方法经过检测限、定量限、溶液稳定性、线性和范围、重复性、准确度的验证。结论:该方法可准确、可靠的定量检测片剂药品中硬脂酸镁含量。Objective:To determine the content of magnesium stearate in tablets.Methods:Gas Chromatography was used with DB-WAX capillary column and FID detector.The injector temperature was 220℃.The detector temperature was 260℃.The column temperature initially kept at 70℃for 2 minutes and then raised to 230℃at the rate of 10℃per minute and hold for 8 minutes.Results:The method has been validated for Limit of Detection,Limit of Quantification,Solution Stability,Linearity and Range,Repeatability and Accuracy.Conclusion:The method can be used for the quantitatively determination of magnesium stearate in tablets accurately and reliably..

关 键 词：硬脂酸镁 气相色谱法 柱前衍生化法 硬脂酸 

分 类 号：O657.7[理学—分析化学]