Determination of Six Elements Extracted from Pharmaceutical High-Density Polyethylene Bottle by Inductively Coupled Plasma Emission Spectroscopy
(Objective)To establish an inductively coupled plasma optical emission spectrometry(ICP-OES)method to determine the content of six elemental impurities,including boron(B),barium(Ba),copper(Cu),silicon(Si),tin(Sn),and zinc(Zn),in the extraction solu-tion of medicinal high-density polyethylene bottle.(Methods)The medicinal high-density polyethylene bottle was extracted with solvent to obtain the extraction solution,which was digested with microwave and analyzed by ICP-OES.(Results)The correlation coefficients of the linear equa-tions for the six elements were all greater than 0.99,the detection limits of the method were 0.004-0.143 μg/g,and the quantification limits of the method were 0.013-0.433 μg/g.The repeatability RSD is between 0.8％and 1.4％.The recovery rate of standard addition is between 80％and 108％.The content of six elemental impurities in the three extraction solutions of medicinal high-density polyethylene bottles did not exceed the method's quantification limit.(Conclusion)The risk of elemental impurity leaching from medicinal high-density polyethylene bottles is relatively low.
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