ICP-MS法同时测定非达霉素片中6种元素杂质  

Simultaneous Determination of Six Elemental Impurities in Fidaxomicin Tablets by ICP-MS

作　　者：班璐 赵静[1] 白青青 马玉玲 程晓昆 高福然 王娅莉 BAN Lu;ZHAO Jing;BAI Qingqing;MA Yuling;CHENG Xiaokun;GAO Furan;WANG Yali(National Engineering Research Center of Microbial Medicine,Hebei Industry Microbial Metabolic Technology Innovation Center,NCPC New Drug Research&Development Co.,Ltd.,Shijiazhuang 052165,China)

机构地区：[1]微生物药物国家工程研究中心、河北省工业微生物代谢技术创新中心、华北制药集团新药研究开发有限责任公司,河北石家庄052165

出　　处：《化学与生物工程》2023年第3期65-68,共4页Chemistry & Bioengineering

基　　金：河北省科技研发平台建设专项(22567651H)。

摘　　要：采用微波消解法对非达霉素片进行前处理后,通过电感耦合等离子体质谱法(ICP-MS)同时测定非达霉素片中6种元素杂质(镍、砷、钒、钴、镉、铅)。在0~50μg·L^(-1)范围内,各元素线性关系良好,检出限在0.0065~0.0688μg·L^(-1)之间,加标回收率在92.15%~103.1%之间,RSD值不超过5%。该方法灵敏度高、准确度好,适用于非达霉素片中元素杂质的检测。We pretreated Fidaxomicin Tablets by a microwave digestion method,and simultaneously determined six elemental impurities(nickel,arsenic,vanadium,cobalt,cadmium,and lead)by inductively coupled plasma mass spectrometry(ICP-MS).In the range of 0-50μg·L^(-1),the linear relationship for each element is good,the limit of detection is 0.0065-0.0688μg·L^(-1),and the recovery is 92.15%-103.1%with the RSD value less than 5%.The method has the characteristics of high sensitivity and accuracy,which is suitable for the determination of elemental impurities in Fidaxomicin Tablets.

关 键 词：ICP-MS 非达霉素片 元素杂质 微波消解 

分 类 号：O657.63[理学—分析化学]