RP-HPLC同时测定华山参滴丸中3种有效成分的含量

Determination of Three Active Components in Huashanshen Dripping Pills by RP-HPLC

目的建立反相高效液相色谱法同时测定华山参滴丸中3种有效成分的含量。方法采用Phenomenex Luna C18色谱柱（4.6 mm×250 mm,5μm）,流动相为20 mmol.L^-1醋酸铵水溶液-甲醇（70∶30）,流速为1.0 mL.min^-1,检测波长215 nm,进样量20μL。结果硫酸阿托品、氢溴酸东莨菪碱和消旋山莨菪碱的线性范围分别为1.444-28.88μg（r=0.999 9）,0.891~17.82μg（r=0.999 9）,2.196~43.92μg（r=0.999 9）;平均回收率（n=6）分别为101.82%（RSD=2.89%）、100.17%（RSD=2.49%）、98.68%（RSD=2.33%）。结论所建立的RP-HPLC方法简便、准确、快速、重复性好,可用于华山参滴丸中硫酸阿托品、氢溴酸东莨菪碱和消旋山莨菪碱3个有效成分的含量测定。

OBJECTIVE To develop a RP-HPLC method for determination of three components（atropine sulfate,scopolamine hydrobromide and raceanisodamine） in Huashanshen dripping pills.METHODS The analysis was performed on a Phenomenex Luna C18 column（4.6 mm×250 mm,5 μm）with the mixture of methanol and 20 mmol· L-1ammonium acetate buffer solution（30∶70） as mobile phase,and the flow rate was 1.0 mL· min-1.The detection wavelength was 215 nm.The column temperature was room temperature（25 ℃）.RESULTS The calibration curves of atropine sulfate,scopolamine hydrobromide and raceanisodamine were linear in the ranges of 1.444-28.88 μg（r=0.999 9）,0.891-17.82 μg（r=0.999 9）,2.196-43.92 μg（r=0.999 9）,respectively.The average recoveries（n=6） of the three components in samples were 101.82%（RSD=2.89%）,100.17%（RSD=2.49%）,98.68%（RSD=2.33%）,respectively.CONCLUSION This method was simple,accurate and reliable to determine the contents of atropine sulfate,scopolamine hydrobromide and raceanisodamine in Huashanshen dripping pills for the quality control.