乙酰半胱氨酸原料药含量测定方法的改进

Optimization of Content Determination Method for Acetylcysteine API

目的:建立电位滴定法测定乙酰半胱氨酸原料药的含量。方法:取样品0.14 g,加水60 ml溶解后,加2 mol·L^(-1)盐酸溶液10 ml,加碘化钾试液10 ml,照电位滴定法用碘滴定液(0.05 mol·L^(-1))滴定,临用新配,并进行相关的方法学验证。结果:乙酰半胱氨酸在0.1021~0.1799 g范围内线性关系良好(r=1.0000),平均回收率为99.4%(RSD=0.2%,n=6)。结论:本法准确度和重复性良好,可用于检测乙酰半胱氨酸原料药的含量。

Objective:To establish a potentiometric titration method for the content determination of acetylcysteine API.Methods:Acetylcysteine API(0.14 g)was dissolved in 60 ml water,and 10 ml hydrochloric acid(2 mol·L^(-1))was added.After 10 ml potassium iodide solution was added,the sample was titrated with iodine titration solution(0.05 mol·L^(-1)),and the end-point was determined potentiometrically.The sample was prepared just before use,and the relevant methodology was verified.Results:Acetylcysteine had a good linear relationship within the range of 0.1021-0.1799 g(r=1.0000),and the average recovery was 99.4%(RSD=0.2%,n=6).Conclusion:The method is accurate and reproducible,and can be used for the content determination of acetylcysteine API.