Objective To determine the content of heavy metal elements in Zhike tablet and evaluate its safety.Methods An ICP-MS method was established for the determination of Ag,As,Ba,Cd,Cr,Cu,Fe,Ni,Pb,Sb,Sn and Zn in Zhike tablets.According to the content of each element and the maximum daily dosage of the drug,the daily exposure amount was calculated and compared with the Permitted Daily Exposure(PDE)amount of element impurities in Chinese Pharmacopoeia.The tablet's safety of heavy metals was evaluated.Results The parameters of ICP-MS method can meet the requirements of analysis,the linear correlation coefficient of standard curve of each element is greater than 0.9995,the detection limit(LOD)and the quantitative limit(LOQ)are low,the precision is high,and the accuracy is well.The test results of certified reference materials(CRM)are consistent with the reference values,the recoveries of the samples spiked by low,medium and high concentration were between 80%and 110%.The contents of tin and antimony in the samples were less than the LOD,silver was less than LOQ and over LOD,iron was the highest,over 200 μg/g,barium was next,about 10 μg/g,copper and zinc were between 1.5-2.8 μg/g,the contents of Cd,As,Cr and Pb were less than 1 μg/g.When compared with PDE value,lead accounted for 91%and other elements less than 10%of daily exposure.Conclusion The ICP-MS method for the determination of twelve heavy metal elements in Zhike tablets is reliable and accurate.The maximum daily exposure of each heavy metal element was within the permitted range,but there was a certain risk in lead.
cough tabletsinductively coupled plasma mass spectrometryheavy metalssafety assessment
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