氟喹诺酮混合溶液标准物质研制

Development of fluoroquinolone mixed solution reference material

建立甲醇中8种氟喹诺酮药物混合溶液标准物质的制备方法。采用重量-容量法配制混合溶液标准物质,以配制值作为标准物质的特性量值,考察不同氟喹诺酮药物之间互为杂质情况,采用高效液相色谱法对标准物质进行均匀性和稳定性检验,并对制备过程产生的不确定度进行评定。研制的甲醇中8种氟喹诺酮药物混合溶液标准物质具有良好的均匀性和稳定性,其质量浓度均为100 mg/L,相对扩展不确定度为2%~3%(k=2),已被批准为国家二级标准物质,编号为GBW(E)083598。该混合溶液标准物质可为农产品质量安全监测与风险评估中氟喹诺酮类药物残留测定提供溯源保障。

The preparation of mixed solution reference material of 8 fluoroquinolones in methanol was built.The reference material of mixed solution was prepared by weight-volume method,the certified value was based on preparation value.The impurities of different fluoroquinolones were investigated,homogeneity and stability test was performed by high performance liquid chromatography method,and the uncertainty of the whole process was evaluated systematically.The reference materials of 8 fluoroquinolones in methanol had good homogeneity and stability,the mass concentration was 100 mg/L,the relative expanded uncertainty was 2%-3%(k=2),and it have been approved as the national second-class reference materials,No.GBW(E)083598.The mixed solution standard material can provide traceability for fluoroquinolones test in program of monitoring and risk assessment of agricultural product.