| 第 51 卷第 3 期 |  | Vol. 51 No. 3 | | 2021 年 6 月 | Jun 2021 |
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所屬欄目：分析與測試
HPLC法測定艾司奧美拉唑鈉原料藥中過(guò)氧化氫異丙苯殘留量 |
| 楊 帥，張治云*
（山東省藥學(xué)科學(xué)院，山東 濟南 250101） |
| 摘 要：建立高效液相色譜法（HPLC）測定艾司奧美拉唑鈉原料藥中過(guò)氧化氫異丙苯殘留量的方法。色譜柱為安捷倫 ZORBAX Eclipse XDB-C8（4.6 mm×250 mm，5 μm），流動(dòng)相為0.01 mol／L磷酸二氫鉀溶液-乙腈，梯度洗脫，流速1.0 mL／min，柱溫30 ℃，進(jìn)樣量10 μL，檢測波長(cháng)210 nm。過(guò)氧化氫異丙苯濃度在0.5~10.0 μg／mL范圍內與峰面積線(xiàn)性關(guān)系良好（r=1.000 0），平均回收率為99.91%（RSD=0.49 %）。方法專(zhuān)屬性、重復性、靈敏度滿(mǎn)足艾司奧美拉唑鈉原料藥中過(guò)氧化氫異丙苯殘留量測定要求。 |
| 關(guān)鍵詞：高效液相色譜；艾司奧美拉唑鈉；過(guò)氧化氫異丙苯 |
| 中圖分類(lèi)號：O657.7+2 文獻標識碼：A 文章編號：1009-9212（2021）03-0073-03 |
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| 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 |
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作者簡(jiǎn)介：楊 帥（1985—），女，山東濟南人，碩士，主管藥師，主要從事新藥研發(fā)和藥物分析工作（E-mail：duguqinshui@163.com）。
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聯(lián) 系 人：張治云，碩士，副主任藥師，主要從事藥物分析工作（E-mail：simmon20001@163.com）。
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收稿日期：2021-05-08
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