第 51 卷第 3 期 Vol. 51 No. 3 2021 年 6 月 Jun 2021

所属栏目：分析与测试 HPLC法测定艾司奥美拉唑钠原料药中过氧化氢异丙苯残留量

杨 帅，张治云* （山东省药学科学院，山东 济南 250101）

摘　要：建立高效液相色谱法（HPLC）测定艾司奥美拉唑钠原料药中过氧化氢异丙苯残留量的方法。色谱柱为安捷伦 ZORBAX Eclipse XDB-C8（4.6 mm×250 mm，5 μm），流动相为0.01 mol／L磷酸二氢钾溶液-乙腈，梯度洗脱，流速1.0 mL／min，柱温30 ℃，进样量10 μL，检测波长210 nm。过氧化氢异丙苯浓度在0.5~10.0 μg／mL范围内与峰面积线性关系良好（r=1.000 0），平均回收率为99.91%（RSD=0.49 %）。方法专属性、重复性、灵敏度满足艾司奥美拉唑钠原料药中过氧化氢异丙苯残留量测定要求。

关键词：高效液相色谱；艾司奥美拉唑钠；过氧化氢异丙苯

中图分类号：O657.7+2　　文献标识码：A　　文章编号：1009-9212（2021）03-0073-03

Determination of Residual Cumene Hydroperoxide in Esomeprazole Sodium by HPLC

YANG Shuai, ZHANG Zhi-yun* (Shandong Academy of Pharmaceutical Sciences, Jinan 250101, China)

Abstract：To establish a method for determination of residual cumene hydroperoxide in esomeprazole sodium by HPLC. An Agilent ZORBAX Eclipse XDB-C8 column(4.6 mm×250 mm, 5 μm) was adopted with DAD detecter. The mobile phase was 0.01 mol/L potassium dihydrogen phosphate-acetonitrile with gradient elution. The detection wavelength was 210 nm, the flow rate was 1.0 mL/min and the column temperature was 30 ℃. A good linear relationship was obtained in the concentration rang of 0.5~10.0 μg/mL for cumene hydroperoxide, with the correlation coefficient of 1.000 0. The average recovery was 99.91%(n=9) , with RSD of 0.49%. The method has good specificity, repeatability and high sensitivity. It can be used for determination of residual cumene hydroperoxide in esomeprazole sodium.

Key words：HPLC; esomeprazole sodium; cumene hydroperoxide

作者简介：杨 帅（1985—），女，山东济南人，硕士，主管药师，主要从事新药研发和药物分析工作（E-mail：duguqinshui@163.com）。

联 系 人：张治云，硕士，副主任药师，主要从事药物分析工作（E-mail：simmon20001@163.com）。

收稿日期：2021-05-08