中药中违法添加枸橼酸西地那非的含量测定方法研究

Determination of Sildenafil Citrate Illegally Added in Chinese Medicinal Preparations

目的:研究补肾壮阳类中药制剂中违法添加枸橼酸西地那非的含量测定方法。方法:将样品经0.01mol/L盐酸提取后采用反相高效液相色谱法进行测定,色谱柱为KromasilC18,流动相为乙腈-水-冰醋酸-三乙胺(35∶65∶0.8∶0.4),流速为0.8ml/min,检测波长为290nm,进样量为10μl。结果:枸橼酸西地那非检测浓度在10～800μg/ml范围内与峰面积积分值线性关系良好,平均加样回收率为98.2%(RSD=0.99%)。结论:本方法可检测该类制剂中违法添加的枸橼酸西地那非。

OBJECTIVE： To study the method for the determination of Sildenafil citrate illegally added in kidney yang tonics, a kind of Chinese medicinal preparation .METHODS： After being extracted by 0.01mol/L hydrochloric acid, the sample was determined by RP HPLC on kromasil - C18 with mobile phase composed of acetonitrile ＂ water- acetic acid glacial triethylamine（35 ： 65 ： 0.8 ： 0.4） at a flow rate of 0.8ml/min .The UV detective wavelength was 290nm and the sample size was 10μl.RESULTS： At a concentration range of 10-800μg/ ml, Sildenafil citrate showed a good linear relation with peak area score.The mean recovery rate was 98.2% （RSD=0.99%） .CONCLUSION： The method can be used to determine Sildenafil Citrate illegally added in kidney yang tonics.