非水滴定法测定泰瑞米特钠的含量  

Determination of terrymitt sodium by non-aqueous titration

作　　者：马燕 李婕[2] 张启明[2] 李慧义[3] MA Yan;LI Jie;ZHANG Qiming;LI Huiyi(Dezhou Center for Food and Drug Control,Dezhou 253015,China;National Institutes for Food and Drug Control,Beijing 100050,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]德州市食品药品检验检测中心,山东德州253015 [2]中国食品药品检定研究院,北京100050 [3]国家药典委员会,北京100061

出　　处：《中国药品标准》2022年第2期210-213,共4页Drug Standards of China

摘　　要：目的:建立泰瑞米特钠容量分析法测定含量。方法:采用非水滴定法,研究了取样量、溶剂和终点指示方式对测定结果的影响。结果:以0.1 mol·L^(-1)高氯酸为滴定液,冰醋酸:醋酐(40∶1)为溶剂,结晶紫为指示剂,滴定终点明显。取样量在0.0636~0.2849 g的范围内,消耗的滴定液体积与取样量呈良好的线性关系(r=0.9999);重复性良好(RSD为0.20%,n=6);供试品溶液4h内稳定性良好。三批样品的平均含量分别为100.5%、100.3%、100.4%。结论:该法经方法学验证,可作为泰瑞米特钠含量测定的方法。Objective:To establish a capacity analysis method for the determination of terrymitt sodium.Methods:Terrymitt sodium assay was performed by non-aqueous titration.Effects of different sampling amount,solvents and indicators on the titration endpoint were compared in this investigation.Results:Using 0.1 mol·L^(-1) perchloric acid as a titrant,acetic acid:acetic anhydride(40∶1)as a solvent and purple crystalas an indicator,the titration endpoint was apparent.The sampling amount in the range of 0.0636-0.2849 g showed a good linear relationship(r=0.9999)with the volume of titrant.Repeatability was good(RSD=0.2%,n=6)and the test solution was stable with in 4 hours.The average contents of three batches of samples were 100.5%,100.3%,100.4%,respectively.Conclusion:The method can be applied to the determination of terrymitt sodium.

关 键 词：泰瑞米特钠 免疫抑制剂 醇钠基团 非水滴定 容量分析法 

分 类 号：R921.2[医药卫生—药学]