HPLC法测定枸橼酸西地那非的含量

Determination of Sildenafil Citrate Content by HPLC

目的：建立枸橼酸西地那非含量及有关物质测定的方法。方法：采用高效液相色谱法，色谱柱为WatersSymme—tryC18柱（250×4．6mm，5μm），等度洗脱方法，流速为1．01nL／min；检测波长为290nm，柱温40℃。结果：枸橼酸西地那非的浓度在100～480μg／mL范围内线性关系良好（v=198．22x＋98．02R=0．999），方法的最低检测限为0．5ng（S／N=3．01）；高、中、低3种浓度的平均回收率（n=3）100．3％（RSD=0．84％）；中间精密度RSD=0．53％（n=6），各杂质峰与主峰达到基线分离。结论：此法操作简单，灵敏、准确、重复性好，适用于枸橼酸西地那非的含量测定。

Objective：To establish a method for content determination of sildenafil citrate and its related substances Methods： using high-performance liquid chromatography, chromatographic column of Waters Symmetry C 18 column （250 x 4.6mm, 5 μ m）, isocratic e- lution method, the flow rate was 1.0mL/min; the detection wavelength was 290nm, the column temperature was 40 ℃. Results：sildenafil citrate concentration in the range of 100 to 480 I.L g/mL good linear relationship （ y = 198.22x ＋ 98.02 R- 0.999 ）, the detection limit is 0.5ng （S/N=3.01）;the average recovery of high, middle,low, 3 kinds of concentration ratio （ n=3 ） 100.3% （RSD=0.84%）;intermediate precision（RSD=0.53% n=6）,the impurity peak and peak reached the baseline separation. Conclusion： the method is simple, sensitive, accurate, reproducible, suitable for the determination of sildenafil citrate.