药用丁基胶塞溶出物2,6-二叔丁基苯酚检测方法的建立

The establishment of method for detection of 2,6-di-tert-butylphenol leachables in rubber closures

根据静注人免疫球蛋白(intravenous human immunoglobulin,pH4)和人血白蛋白的性质,选择高氯酸作为沉淀剂,磷酸三丁酯作为内标,建立血液制品中2,6-二叔丁基苯酚的检测方法,同时利用专属性、准确性、重复性、线性、定量限、范围、中间精密度7个内容确认该方法是否有效.结果表明建立的方法在测定2,6-二叔丁基苯酚过程中无蛋白质干扰,且2,6-二叔丁基苯酚和内标磷酸三丁酯具备较好的分离度,各验证结果均符合预期要求,仪器定量限为0.3μg/mL.

According to the properties of intravenous human immunoglobulin （pH4） and human serum albumin, perchloric acid was selected as precipitant reagent and tributyl phosphate as internal standard to detect the 2,6-di-tert-butylphenol content in the blood products. Then the method was verified by the specificity, accuracy, repeatability, linearity, limit of quantification, range and intermediate precision. The results demonstrated this method was feasible without protein interference, 2,6-di-tert-butylphenol and the internal standard of tributyl phosphate were well separated in this method. Moreover, each veri- fication result was consistent with the expectation, and the limit of quantitation was 0.3 μg/mL.