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目的 :建立氢溴酸加兰他敏及其分散片的HPLC分析方法。方法 :采用ODS色谱柱 (15 0mm× 4 .6mm ,5 μm) ,以甲醇 水 冰醋酸 (75∶92 5∶10 )为流动相 ;流速 :1.0ml·min-1,检测波长 :2 89nm ;采用外标法测定氢溴酸加兰他敏分散片的含量。结果 :氢溴酸加兰他敏在 10～ 10 0 μg·ml-1范围内 ,线性关系良好 (r =0 .9998) ;平均回收率为 10 0 .2 % ;日内精密度(RSD =0 .6 % ,n =5 )良好。结论 :本法适用于氢溴酸加兰他敏及其分散片的含量测定 ,方法简便、准确、快速。
Objective: To establish an HPLC method for analysis of galantamine hydrobromide and its dispersible tablets. Methods: ODS column (150 mm × 4.6 mm, 5 μm) was used with mobile phase consisting of methanol-water glacial acetic acid (75:92:10), flow rate 1.0 ml · min-1, detection wavelength 2989 nm, External standard method for the determination of galantamine hydrobromide dispersible tablets. Results: Galanthamine hydrobromide had a good linearity (r = 0.9998) in the range of 10 ~ 100 μg · ml-1. The average recovery was 100.2%. Intraday precision (RSD = 0 .6%, n = 5) is good. Conclusion: This method is suitable for the determination of galantamine hydrobromide and its dispersible tablets. The method is simple, accurate and rapid.