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氢溴酸高乌甲素分散片的有关物质测定方法及稳定性研究
引用本文:胡雪莲,雷健,王芳,张恩娟. 氢溴酸高乌甲素分散片的有关物质测定方法及稳定性研究[J]. 中国药业, 2012, 21(16): 29-31
作者姓名:胡雪莲  雷健  王芳  张恩娟
作者单位:中国人民解放军第三军医大学新桥医院药剂科,重庆,400037
摘    要:目的 建立测定氢溴酸高乌甲素分散片有关物质的高效液相色谱(HPLC)法,并考察其稳定性.方法 色谱柱为Diamonsil C18柱(250 mm×4.6 mm,5μm),0.05 mol/L磷酸二氢钠一甲醇(28:72)为流动相,检测波长为252 nm,流速1.0 mL/min,柱温为25℃.结果 在该色谱条件下,各杂质峰与主峰均能良好分离,检测限为0.32 ng.结论 该方法简便快捷,准确实用,适用于氢溴酸高乌甲素分散片的质量控制.

关 键 词:氢溴酸高乌甲素  分散片  有关物质  高效液相色谱法  稳定性

Determination and Stability of Related Substances in Lappaconitine Hydrobromide Dispersible Tablets
Hu Xuelian , Lei Jian , Wang Fang , Zhang Enjuan. Determination and Stability of Related Substances in Lappaconitine Hydrobromide Dispersible Tablets[J]. China Pharmaceuticals, 2012, 21(16): 29-31
Authors:Hu Xuelian    Lei Jian    Wang Fang    Zhang Enjuan
Affiliation:(Department of Pharmacy,Xinqiao Hospital,Third Military Medical University,Chongqing,China 400037)
Abstract:Objective To establish a HPLC method for the determination of related substances in lappaconitine hydrobromide dispersible tablets,and to investigate their stability.Methods The HPLC analysis was performed on Diamonsil C18 column(250 mm×4.6 mm,5 μm)using 0.05 mol/L NaH2PO4-methanol(28 ∶72)as the mobile phase with detection at 252 nm,flow rate of 1.0 mL/min and column temperature was 25 ℃.Results Good resolution for lappaconitine hydrobromide dispersible tablets and related substances was obtained.The detection limit was 0.32 ng.Conclusion The method is simple,sensitive,accurate and can be used in quality control of lappaconitine hydrobromide dispersible tablets.
Keywords:lappaconitine hydrobromide  dispersible tablets  related substances  HPLC  stability
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