Determination of 20 elements impurities in Salbutamol Sulfate Inhalation Aerosol by ICP-MS

ZHANG Lianyi; CHEN Zhen; LIU Zhongyuan; NIU Chong; LI Wenxin; ZHENG Jing; DOU Yanli; GUO Changchuan; LIU Qi; XU Yuwen

doi:10.13506/j.cnki.jpr.2025.03.005

Abstract：Objective To establish an inductively coupled plasma mass spectrometry(ICP-MS)method for the deter-mination of inorganic element impurities in Salbutamol Sulfate Inhalation Aerosol,and application in national drug sampling samples.Methods According to the ICH guiding principle Q3D(R2):Guideline for Elemental Impurities and semi-quan-titative analysis,the types of elements to be analyzed were determined,including 20 elements:Li,B,Si,Al,Ti,V,Cr,Co,Ni,Cu,Zn,As,Mo,Cd,Sn,Sb,Ba,Au,Hg,Pb;The internal standard correction standard curve method was used for deter-mination.Results The established internal standard calibration curve method was able to accurately determine the assay of elemental impurities within the linear range of each impurity,and the linear correlation coefficients were all higher than 0.999.Among the sampled samples from four enterprises,the average detection value of Class 1 element Pb in enterprises a,c,and d ranges from 0.02 to 0.03 ng·mL-1,with a maximum value of 0.054 ng·mL-1.Other Class 1 elements Cd,Hg,and As were not detected.Class 2A elements Co and V were not detected,while the average detection of element Ni ranged from 0.2 to 0.5 ng·mL-1.Three types of elements Sb,Ba,Mo,and Sn were not detected.Trace amounts of elements Li,Cu,and Cr were detected,with an average of 0.10～0.13 ng·mL-1 for element Li and 0.2～0.4 ng·mL-1 for element Cu.The average val-ue of element Cr ranges from 0.11 to 1.5 ng·mL-1.Among the elements selected for semi-quantitative analysis,a large a-mounts of elements B,Al,Si,and Zn were detected.Conclusion The established method is sensitive,accurate,simple,can effectively determine the inorganic element impurities in salbutamol sulfate inhalation aerosol.