HPLC分析7种抗氧剂在注射用盐酸吉西他滨中的迁移情况

Analyzation of the Migration of Seven Kinds of Antioxidants in Gemcitabine Hydrochloride for Injection by HPLC

目的:建立测定注射用盐酸吉西他滨中抗氧剂迁移量的方法。方法:采用Inertsil ODS-3色谱柱(4.6 mm×250 mm,5μm),以甲醇为流动相A、1%醋酸为流动相B进行梯度洗脱,流速1.0 mL/min,柱温35℃,检测波长277 nm。结果:7种抗氧剂在各自的检测浓度范围内均呈现良好的线性关系(r均为1.0000);各抗氧剂平均回收率89.7%~98.9%(RSD均小于2.0%,n=9)。结论:该方法操作简便、准确度较高,可用于注射用盐酸吉西他滨胶塞相容性试验中抗氧剂迁移分析。

Objective:To establish a method for determination of the migration of antioxidants in gemcitabine hydrochloride for injection.Methods:A linear gradient program was performed with methanol as mobile phase A and 1%glacial acetic acid as mobile phase B,using Inertsil ODS-3 column(4.6 mm×250 mm,5μm).The flow rate was 1.0 mL per minute and the column temperature was maintained at 35℃.The detection wavelength was 277 nm.Results:Seven kinds of antioxidants showed good linear relationship in their corresponding concentration ranges(r=1.0000).The average recoveries were between 89.7%and 98.9%(RSD<2.0%,n=9).Conclusion:The method is simple and accurate,which can be used to evaluate the migration of antioxidants from rubber closures to gemcitabine hydrochloride for injection.