反相高效液相色谱法测定鬼臼毒素和丙酸倍氯米松的含量

Determination of the Contents of Podophyllotoxin and Beclometasone Dipropionate in a Preparation by RP-HPLC

目的 :建立反相高效液相色谱法测定鬼臼毒素和丙酸倍氯米松含量的方法。方法 :采用SB -C18 为固定相的色谱柱 ,甲醇 -水(70∶30)为流动相 ,流速为0 8ml/min ,紫外检测波长为262nm ,柱温为25℃ ,用外标两点法定量。结果 :该方法下鬼臼毒素标准曲线为Y=0 3594X +0 2667 ,r=0 9999(n=5) ,线性范围为5～350μg/ml,回收率98 03 %～99 60 % (n=5) ;丙酸倍氯米松标准曲线为Y=1 462X—0 08 ,r=0 9999(n=5) ,线性范围为3～40μg/ml ,回收率为98 82 %～101 70 % (n=5) ;鬼臼毒素和丙酸倍氯米松的日内RSD分别为0 86 %和1 63 % (n=5) ,日间RSD分别为1 94 %和2 02 % (n=10)。结论 :该方法准确可靠、重现性好 。

OBJECTIVE:To develop a RP-HPLC method for the determination of the contents of podophyllotoxin and beclometasone dipropionate in a preparation METHODS:Detection was performed on Zorbax SB-C18 column(4 6mm×150mm,5μm)with methanol-water(70∶30) as mobile phase,and UV-detection wavelength was 262nm and external standard method was adopted RESULTS:The standard curves of podophyllotoxin and beclometasone dipropionate were Y=0 3 594X+0 2 667,r=0 9 999(n=5)and Y=1 462X-0 08,r=0 9 999(n=5)respectively The linear ranges of podophyllotoxin and beclometasone dipropionate were 5～350μg/ml and 3～40μg/ml respectively The average recoveries of podophyllotoxin and beclometasone dipropionate were 98 03%～99 60% and 98 82%～101 70% respectively The within-day and between day RSD were 0 86% and 1 63%,1 94% and 2 02% respectively CONCLUSION:The method is accurate,reliable and good in reptiveness,and can be used for quality control of preparations