HPLC法测定原料药中埃索美拉唑的含量

Content determination of esomeprazole in bulk drug by HPLC

目的建立用于测定原料药中埃索美拉唑含量的HPLC法。方法采用HPLC法测定，色谱柱：WatersXTerraCSC8反相柱（150mm×4．6mm，3．5um），流动相：V（乙腈）：V（20mmol／L醋酸铵缓冲液，pH7．6）=28：72，检测波长280rim，柱温25℃，流速1mL／min。结果埃索美拉唑浓度在0．01～0．07mg／mL范围内与峰面积之间呈现良好的线性关系（r=0．9996），方法回收率为98．49％～101．72％，RSD为0．15％～0．58％。结论本方法简便快速，能准确检测原料药中埃索美拉唑的含量，可作为原料药质量控制的分析方法。

Objective To establish an HPLC method for the determination of esomeprazole in bulk drug. Methods HPLC was applied to determine the test drug with Waters XTerra MS C8 column （150 mm × 4. 6 mm, 3.5 um）. The mobile phase was V （acetonitrile）： V （20 mmol/L, ammonium acetate,pH 7.6） = 28.72, the measurement wavelength was 280 nm, the column temperature was 25 C and flow rate was I mL/min. Results The linear range was 0. 01 - 0. 07 mg/mL （r = 0.9996）. The method recovery rate and RSD was 98. 49% - 101. 72% and 0. 15% - 0. 58%, respectively. Conclusions This methodissimple, fast, and can be accurately used for the determination of esomeprazole in bulk drug. Therefore, it can be used as an effective quality control method for esomeprazole bulk drug.