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  

Determination of Residual Cumene Hydroperoxide in Esomeprazole Sodium by HPLC

作　　者：杨帅 张治云 YANG Shuai;ZHANG Zhi-yun(Shandong Academy of Pharmaceutical Sciences,Jinan 250101,China)

机构地区：[1]山东省药学科学院,山东济南250101

出　　处：《精细化工中间体》2021年第3期73-75,共3页Fine Chemical Intermediates

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,5μm),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10μL,检测波长210 nm。过氧化氢异丙苯浓度在0.510.0μg/mL范围内与峰面积线性关系良好(r=1.0000),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。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,5μm)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 0.5~10.0μg/mL for cumene hydroperoxide,with the correlation coefficient of 1.0000.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.

关 键 词：高效液相色谱 艾司奥美拉唑钠 过氧化氢异丙苯 

分 类 号：O657.71[理学—分析化学]