Determination of the Elemental Impurities in Pharmaceutic Adjuvant tert-Butanol by ICP-MS
An ICP-MS method was established for the determination of elemental impurities,namely Cd,Pb,As,Hg,Co,V,Ni,Li,Sb,Cu in tert-butanol.The microwave digestion method was used,and the sample was digested with a nitric acid-hydrochloric acid mixed solution.After eliminating matrix interference and instrument drift through online internal standards,the measurement was carried out.The results showed that the quantification limits of Cd,Pb,As,Hg,Co,V,Ni,Li,Sb,and Cu were 0.028 8,0.179 8,0.057 6,0.229 4,0.015 3,0.025 3,0.232 2,1.226 0,0.021 9,and 0.138 6 ng/mL,respectively,all of which were less than 5％of the limit values and met the detection requirements.The RSDs of repeatability and precision were both less than 20％.Within 25％to 300％of the limit concentration range,it was linear for the ten elemental impurities,with recovery rates ranging from 90％to 120％.The established ICP-MS method is convenient,fast,highly sensitive,and accurate,which provide a technical support for the quality control research of tert-butanol.
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