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

Determination and Stability of Related Substances in Lappaconitine Hydrobromide Dispersible Tablets

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-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。

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.