高效液相色谱法测定泮托拉唑钠肠溶微丸胶囊的含量

Determination of Pantoprazole in Enteric-coated Micropill Capsule by HPLC

目的建立高效液相色谱(HPLC)法测定泮托拉唑钠肠溶微丸胶囊的含量。方法采用HPLC法,色谱柱为Symetry C18柱(4.6mm×150mm,5μm),流动相:0.025mol·L-1磷酸二氢钾缓冲液-乙腈(70:30),柱温35℃,流速1.0mL·min-1,检测波长:288nm。结果所选定的条件下样品峰分离良好,泮托拉唑钠在36～84mg·L-1范围内线性关系良好,线性回归方程为Y=13130C+155709(r=0.9997),精密度、回收率RSD均<3%,平均回收率100.40%,RSD=1.23%。3批泮托拉唑钠肠溶微丸胶囊的标示含量平均值为99.53%。结论该法简便快速,灵敏准确,可用于测定泮托拉唑钠肠溶微丸胶囊的含量。

Objective To establish a HPLC method for determination of pantoprazole in enteric-coated micropill capsule. Methods Symetry C18 （4.6 mm × 150 mm,5 μm）column was employed as a stationary, mixture of acetonitrile and phosphate buffer （70： 30） as a mobile phase. The detection wavelength was 288 nm, the flow rate was 1.0 mL·min^-1. Results The sample was well isolated under the condition. The linear relationship was good for pantoprazole at the range of 36- 84 mg·L^-1, the function was Y= 13 130C ＋ 155 709 （r =0.999 7）. The RSD of precision and recovery was less than 3% and the content of pantoprazole was 99.53%. Conclusion This method is accurate, convenient and fast, which is suitable for determination of pantoprazole in enteric-coated micropill capsule.