高效液相色谱法测定氢溴酸高乌甲素分散片的含量

目的 建立测定氢溴酸高乌甲素分散片含量的高效液相色谱法.方法 色谱柱为Diamonsil C18柱(250mm×4.6mm,5μm),以0.05mol/L磷酸二氢钠-甲醇(28∶72)为流动相,检测波长为252 nm,流速为1.0mL/min.结果 在该色谱条件下,各杂质峰与主峰均能良好分离；氢溴酸高乌甲素质量浓度在11.85～158.00μg/mL范围内与峰面积呈良好线性关系,回归方程为Y=19 196X+ 156.22(r=1);平均回收率为100.03％,RSD为0.71％(n=9).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.

Content Determination of Lappaconitine Hydrobromide Dispersible Tablets by HPLC

Objective To establish an HPLC method for determination of Lappaconitine Hydrobromide Dispersible Tablets.Methods The HPLC system consisted of Diamonsil C18 column（250 mm×4.6 mm,5 μm）,0.05 mol/L NaH2PO4-methanol（28 ∶72） as the mobile phase with detection wavelength at 252 nm,flow rate was 1.0 mL/min,column temperature was 25 ℃.Results Good resolution for Lappaconitine Hydrobromide Dispersible Tablets and related substances was obtained.The linear range was 11.85-158.00 μg/mL（r=1）.The average recovery was 100.03%,with RSD of 0.71%.Conclusion The method is simple,sensitive,accurate and can be used in quality control of Lappaconitine Hydrobromide Dispersible Tablets.