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氢溴酸加兰他敏含量测定的方法比较

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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。
Comparison of content determination methods for galantamine hydrobromide
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.

Galantamine hydrobromidePotentiometric titrationContent determinationHPLC

刘静兰

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厦门市食品药品质量检验研究院,福建厦门 361012

氢溴酸加兰他敏 电位滴定 含量测定 高效液相色谱法

2024

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2024.22(2)
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