【摘要】：目的建立反相高效液相色譜法測定枸櫞酸西地那非原料藥的含量及有關物質。方法采用Phenomenex Luna C18色譜柱(250 mm×4.60 mm,5μm),流動相:0.05 mol·L-1磷酸三乙胺(取7 m L三乙胺用水稀釋至1 000 m L,用磷酸調p H至4.0±0.1)-甲醇-乙腈(體積比為58∶25∶17),流速:1.0 m L·min-1,柱溫:30℃,檢測波長:290 nm,進樣量:20μL。結果枸櫞酸西地那非與各有關物質、降解產物均能良好的分離,西地那非的質量濃度在17.12~39.94 mg·L-1內線性關系良好(r=0.999 9),重復性好(RSD=0.3%),中間精密度佳(RSD=0.6%),平均回收率為100.7%(RSD=0.4%,n=9),檢測限(S/N=3)為2.10 ng。結論本法可用于枸櫞酸西地那非原料藥含量測定和有關物質檢測。
[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 鹵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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