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.
出处
《黑龙江医药》
CAS
2013年第5期755-757,共3页
Heilongjiang Medicine journal