HPLC法测定三层共挤输液袋装氯化钠和葡萄糖注射液中抗氧剂迁移量

Determining the Migration Amount of Antioxidant in Sodium Chloride and Glucose Injection with 3-layer Co-extrusion Infusion Bag by HPLC

目的建立高效液相(HPLC)测定三层共挤输液袋装氯化钠和葡萄糖注射液中抗氧剂的方法,研究抗氧剂向注射液迁移情况。方法采用固相萃取制备供试品溶液,建立HPLC测定三层共挤输液袋装氯化钠和葡萄糖注射液中抗氧剂迁移量的方法。结果抗氧剂1010、抗氧剂330、抗氧剂1076、抗氧剂168分别在1.0～200μg·mL-1、0.5～200μg·mL-1、0.5～200μg·mL-1、3～200μg·mL-1范围内线性关系良好(R2≥0.9999)。平均回收率在87.7%～100.6%,RSD≤3.3%。结论本方法操作方便、分析精密度高、准确度可靠、可用于三层共挤输液袋装氯化钠和葡萄糖注射液中抗氧剂的迁移量测定。

OBJECTIVE To establish a HPLC method for determining the amount of antioxidant in sodium chloride and glucose injection with 3-layer co-extrusion infusion bag,study the migration behavior of antioxidant from bags to injection.METHODS Solid phase extraction was used to prepared sample solution,and method for determining the content of antioxidant in sodium chloride and glucose injection with 3-layer co-extrusion bag was established.RESULTS The linear concentration ranges of antioxidant 1010,330,1076 and 168 were 1.0-200μg ·mL-1、0.5-200μg·mL-1、0.5-200μg·mL-1、3-200μg·mL-1,respectively(R2≥0.9999).The average recovery was range from 87.7% to 100.6%(RSD≤3.3%).CONCLUSION The method is convenient,accurate,reliable and it can be used for the determination of antioxidant in sodium chloride and glucose injection with 3-layer co-extrusion infusion bag.