RP-HPLC法测定补肾壮阳中药制剂中违法添加的枸橼酸西地那非

Determination of Sildenafil Citrate Illegally Added in Kidney-yang Reinforcing Chinese Medicinal Tonics by RP-HPLC

目的：建立以反相高效液相色谱法测定补肾壮阳中药制剂中违法添加枸橼酸西地那非的方法。方法：色谱柱为ODSC18（250mm×4．6mm，5μm），流动相为甲醇-水-冰醋酸-三乙胺（60：40：0．8：0．3），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10～100μg·mL^-1范围内与峰面积积分值呈良好线性关系；平均加样回收率为100．52％，RSD=1．20％。结论：本方法可用于检测补肾壮阳类中药制剂中违法添加的枸橼酸西地那非。

OBJECTIVE ： To determine the content of Sildenafil citrate illegally added in kidney - yang reinforcing Chinese medicinal tonics. METHODS： The samples were separated on ODS C18（250 mm × 4.6 mm, 5 μm） with mobile phase consisted of methanol - water - acetic acid glacial - triethylamine（60 ： 40 ： 0.8 ： 0.3） at a flow rate of 0.8 mL · min^ -1.The UV detective wavelength was 290 nm and the sample size was 10 μL. RESULTS： At a concentration range of 10-100μg · mL^-1, Sildenafil citrate showed a good linear relation with peak area score. The mean recovery rate was 100,52 % （RSD =1.20 % ）. CONCLU- SION：The method can be used to determine Sildenafil Citrate illegally added in kidney- yang tonics,