目的: 建立HPLC法测定疫苗中硫柳汞的含量,与2020年版《中华人民共和国药典》收载的测定法进行比较。方法: 采用C18色谱柱(4.6 mm×250 mm,5 μm),以甲醇- 0.05%三氟醋酸溶液(60∶40)为流动相;检测波长为222 nm,柱温为30 ℃。结果: 本法测定样品中硫柳汞的含量,与2020年版《中华人民共和国药典》测定无机汞离子含量结果存在一定差异。结论: 硫柳汞在疫苗生产过程中易降解,本法专属性好,可以更准确地测定疫苗中硫柳汞的含量。
Objective: To establish an HPLC method for the detection the assay of thiomersal in vaccine, and compare the result with the content determined by ChP 2020 method. Methods: The analysis was carried out on C18 column(4.6 mm×250 mm,5 μm) with mobile phase of methanol and 0.05% trifluoroacetic acid solution (60∶40). The experimentwas carried out at 30 ℃ with the UV detection at 222 nm. Results: There was a certain difference between the content of thiomersal calculated by external standard and ChP 2020. Conclusions: Thiomersal can be degraded in the production process. The method has good specificity and can be used to determine the content of thiomersal in vaccine.
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