HPLC法测定注射用布比卡因凝胶中抗氧剂1010和抗氧剂1076的含量

Determination of Antioxidant 1010 and Antioxidant 1076 in Bupivacaine Gel by HPLC

借助高效液相色谱仪对注射用布比卡因凝胶中抗氧剂1010和抗氧剂1076的含量进行测定。结果表明,新方法检测抗氧剂1010和抗氧剂1076分别在1.00～～40.0μg/mL和2.04～81.6μg/mL范围内线性关系良好,相关系数都为0.9999,抗氧剂1010和抗氧剂1076在注射用布比卡因凝胶中平均加标回收率为90.4%(RSD=4.76%)和86.4%(RSD=3.95%),该方法灵敏快速,操作简便,重复性好,可用于检测包装材料中抗氧剂1010和抗氧剂1076在注射用布比卡因凝胶中的迁移情况。

A method was established for determination of antioxidant 1010 and antioxidant 1076 in bupivacaine gel by HPLC.The results showed that the new method have a good linearity in the range of 1.00-40.0μg/mL for antioxidant 1010(R=0.9999),2.04~81.6μg/mL for antioxidant 1076(R=0.9999),the average recovery of antioxidant 1010 was 90.4%(RSD=4.76%),and the average recovery of antioxidant 1076 was 86.4%(RSD=3.95%).The method is sensitive,rapid,easy to operate and reproducible,and can be used for detecting the migration of the antioxidant 1010 and the antioxidant 1076 in the packaging material to the bupivacaine gel for injection.