HPLC法测定枸橼酸西地那非原料药的含量及有关物质

发布时间：2018-10-05 10:02

【摘要】：目的建立反相高效液相色谱法测定枸橼酸西地那非原料药的含量及有关物质。方法采用Phenomenex Luna C18色谱柱(250 mm×4.60 mm,5μm),流动相:0.05 mol·L-1磷酸三乙胺(取7 m L三乙胺用水稀释至1 000 m L,用磷酸调p H至4.0±0.1)-甲醇-乙腈(体积比为58∶25∶17),流速:1.0 m L·min-1,柱温:30℃,检测波长:290 nm,进样量:20μL。结果枸橼酸西地那非与各有关物质、降解产物均能良好的分离,西地那非的质量浓度在17.12~39.94 mg·L-1内线性关系良好(r=0.999 9),重复性好(RSD=0.3%),中间精密度佳(RSD=0.6%),平均回收率为100.7%(RSD=0.4%,n=9),检测限(S/N=3)为2.10 ng。结论本法可用于枸橼酸西地那非原料药含量测定和有关物质检测。
[Abstract]:Objective to establish a RP-HPLC method for the determination of sildenafil citrate and its related substances. Methods Phenomenex Luna C18 column (250 mm 脳 4.60 mm,5 渭 m),) was used as mobile phase: 0. 05 mol L-1 triethylamine phosphate (diluted to 1 000 mL with water and adjusted with phosphoric acid to 4.0 卤0. 1) -methanol-acetonitrile (58:25:17 by volume ratio). The flow rate was 1.0 mL min-1, at 30 鈩，

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