非水电位滴定法测定盐酸特比萘芬原料药含量方法的改进

目的:改进非水电位滴定法测定盐酸特比萘芬原料药含量的方法。方法:采用电位滴定法,以冰醋酸为溶剂,用适量醋酐代替现行标准中使用的醋酸汞,建立了测定盐酸特比萘芬原料药含量的方法;同时将改进前、后方法的测定结果进行比较。结果:改进后方法突跃增大,重复性试验RSD<0.15%;改进前、后方法测定结果比较,相对偏差最大值为0.1%。结论:改进后方法不但革除了汞盐、使滴定突跃更加明显,且操作简便、快速,可用于盐酸特比萘芬原料药的含量测定。

Optimization of the Determination Method of Terbinafine Hydrochloride by Non-aqueous Potentiometric Titration

OBJECTIVE： To improve the determination method of terbinafine hydrochloride by non-aqueous potentiometric titration.METHODS： Potentiometric titration was adopted to determine the content of terbinafine hydrochloride using glacial acetic acid as solvent,acetic anhydride instead of mercury acetate.Results of improved determination method were compared with that of primary method.RESULTS： One abrupt change was obtained in the titration curve.The repeatability precision RSD was lower than 0.15%.Results of improved determination method were compared with that of primary method with maximum deviation of 0.1%.CONCLUSION： Improved method not only discards mercuric salt but also obtain obvious abrupt change of titration curve.It is simple and rapid for the determination of terbinafine hydrochloride.