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目的:建立氢溴酸加兰他敏片简便、准确的含量测定方法。方法:氢溴酸加兰他敏在289nm波长处有最大吸收,采用紫外分光光度法测定氢溴酸加兰他敏片的含量,以0.1mol/L盐酸为溶剂,能消除辅料对主药的吸收作用。通过标准曲线的制备,得出浓度与吸收度的回归方程。并做24小时室温下稳定性试验、回收率试验样品测定和含量均匀度测定。结果:平均回收率为100.2％,RSD为0.41％;含量均匀度测定符合《中国药典》规定;对照品和样品测定溶液在24小时内稳定。结论:以本法测定氨溴酸加兰他敏片的含量,结果准确,方法简便。
Objective: To establish a simple and accurate method for the determination of galantamine hydrobromide. Methods: The galantamine hydrobromide has the maximum absorption at 289nm. The content of galanthamine hydrobromide was determined by UV spectrophotometry. When 0.1mol / L hydrochloric acid was used as the solvent, Absorption. Through the preparation of standard curve, the regression equation between concentration and absorbance was obtained. And 24 hours at room temperature stability test, recovery test sample determination and content uniformity determination. Results: The average recovery was 100.2% with RSD of 0.41%. The determination of content uniformity was in accordance with the requirements of the Chinese Pharmacopoeia. The reference solution and the sample were stable within 24 hours. Conclusion: This method for the determination of glycopyrrolate galantamine tablets content, the results are accurate, the method is simple.