HPLC法测定枸橼酸西地那非的含量

摘要

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Waters Symme-try C18柱（250×4.6mm，5μm），等度洗脱方法，流速为1.0mL/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（y=198.22x+98.02 R=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 C18 column(250×4.6mm,5μm), 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 480μg/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.