对《中国药典》2010年版盐酸精氨酸含量测定方法的改进

Methods Improvement in the Determination of Arginine Hydrochloride in Chinese Pharmacopoeia(2010 edition)

目的:建立《中国药典》2010年版盐酸精氨酸含量测定中革除汞盐的方法。方法:采用电位滴定法,用醋酸钠滴定液对高氯酸进行返滴定。结果:空白溶液不干扰测定,方法精密度为99.5%(RSD=0.22%,n=6),准确度良好,测定值与真实值相对偏差为0.05%,供试品溶液在4 h内稳定。革除汞盐后方法含量测定结果与原方法测定结果基本一致,可代替原方法。结论:该方法简便、易行,精密度与准确度良好,可用于盐酸精氨酸含量测定。

Objective： To establish the determination method for arginine hydrochloride after removing mercuric acetate in Chinese pharmacopoeia （2010 edition）. Methods： Using potentiometric titration, perehloric acid was reverse titrated by sodium acetate volumetric solution. Results： The blank solution showed no interference with the determination, the precision was 99.5 % （ RSD = 0.22% , n = 6） , and the accuracy was good. The relative deviation of the determination value and the real value was 0.05% , and the sample solution was stable in 4 hours. The determination after removing mercury salt was consistent with the original method, which could replace the original method. Conclusion： The method is simple and feasible with good precision and accuracy, and can be used in the determination of arginine hydrochloride.