非水电位滴定法测定盐酸非索非那定原料药含量方法的改进

Optimization for the determination method of fexofenadine hydrochloride by non-aqueous potentiometric titration

目的:改进非水电位滴定法测定盐酸非索非那定原料药含量的方法。方法:采用电位滴定法,以冰醋酸-醋酐(1∶3)为溶剂,革除现行标准中醋酸汞的使用,建立了测定盐酸非索非那定原料药含量的方法。结果:改进后的方法突跃明显增大,测定结果与高效液相色谱法测定结果无显著差异。结论:改进后的方法不但革除了醋酸汞的使用,且操作简便、快速、重复性好,可用于盐酸非索非那定原料药的含量测定。

Objective： To optimize the determination method of fexofenadine hydrochloride by non-aqueous potentiometric titration. Methods： The new determination method of fexofenadine hydrochloride was established with nonaqueous potentiometric titration. Glacial acetic acid-acetic anhydride（ 1 ∶ 3） was used as the solvent to avoid the use of mercuric acetate. Results： The optimized method had the sharpness titration jump. There was no significant difference between the results obtained by the improved method and HPLC method. Conclusion： The optimized method avoids the use of mercuric acetate. It is simple and rapid,and has the good repeatability. It can be used for the determination of fexofenadine hydrochloride.