氢溴酸加兰他敏含量测定的方法比较

Comparison of content determination methods for galantamine hydrobromide

目的对氢溴酸加兰他敏不同含量测定方法进行比较研究,为完善其质量标准提供依据。方法参照《中国药典》2020年版、《英国药典》2023年版、《欧洲药典》11.0版、《美国药典》2023年版和相关文献分别采用非水溶液滴定法、酸碱电位滴定法和高效液相色谱法测定氢溴酸加兰他敏的含量。结果非水溶液滴定法的平均回收率为99.79%(RSD=0.46%);酸碱电位滴定法的平均回收率为100.67%(RSD=0.32%);高效液相色谱法的平均回收率分别为99.78%(RSD=0.82%)和99.85%(RSD=0.66%)。结论酸碱电位滴定法的含量测定结果偏高,非水溶液滴定法和高效液相色谱法的测定结果较为准确,更适用于氢溴酸加兰他敏的含量测定。

Objective To comparative study on different content determination methods of galantamine hydrobromide,in order to provide a foundation for the improvement of quality standard.Methods The contents of galantamine hydrobromide were determined by non-aqueous titration,acid-base potentiometric titration and high performance liquid chromatography,with reference to the Chinese Pharmacopoeia 2020,British Pharmacopoeia 2023,European Pharmacopoeia 11.0,United States Pharmacopoeia 2023 and relevant literature.Results The average recovery of non-aqueous titration was 99.79%(RSD=0.46%);the average recovery of acid-base potentiometric titration was 100.67%(RSD=0.32%);the average recoveries of high-performance liquid chromatography were 99.78%(RSD=0.82%)and 99.85%(RSD=0.66%),respectively.Conclusion The content results of acid-base potentiometric titration were higher,while the results of non-aqueous titration and HPLC were more accurate,which are more suitable for the content determination of galantamine hydrobromide.