摘要
建立甘露醇中元素杂质含量测定的方法。采用硝酸为消解体系经微波消解甘露醇,电感耦合等离子体质谱法(ICP-MS)测定其中的元素杂质含量,为校正响应信号的变化及消除了基体效应和仪器漂移的影响,选用Bi、Ge、In、Rh、Sc、Tb和Y做内标溶液测定。方法测定各杂质元素在限度浓度范围内具有良好的线性关系,结果的准确度和精密度均符合要求。试验结果表明,该方法稳定、重复性、线性和精密度好,可以用于测定甘露醇中元素杂质的含量。
To establish the method of determining the contents of elements impurities in the mannitol.The mannitolwas digested by nitric acid,and the content of elements impurities belonging to the mannitolwas determined by ICP-MS.The internal standard reference was Bi,Ge,In,Rh,Sc,Tb and Y.The linearity of elements impuritieswas good,and accuracy,precision,specificity and LOQ were complied with the rules.The method is stable,and reproducibility,linear and precision was good.This method could be used to determining the contents of elements impurities in the mannitol.
作者
陈佩琪
Chen Peiqi(Dandong Drug Inspection and Examination Center,Dandong,Liaoning 118000,China)
出处
《化工与医药工程》
CAS
2023年第5期39-44,共6页
Chemical and Pharmaceutical Engineering