HPLC测定枸橼酸西地那非片中西地那非及其有关物质的含量

Determination of Sildenafil Citrate and Its Related Compound in Tablet by RP-H PLC

目的 建立 RP-HPLC测定枸橼酸西地那非片中西地那非及其有关物质的含量。方法 以乙腈 -水 (4 4∶ 5 6,v/v)为流动相 ,Hypersil ODS-2色谱柱 (5μm,2 0 0 mm× 4 .6mm)为固定相 ,流速为 1 ml/min,检测波长为 2 92 nm。结果 西地那非在 2 0～ 80μg/ml浓度范围内线性关系良好 ,RSD为 1 .2 7% ,平均回收率为 99.4 8% ,最低检测限为 0 .1 μg/ml。

AIM\ A rapid and sensitive reversed-phase high-performance liq ui d chromatographic method for the determination of sildenafil and its related com pound in sildenafil citrate tablet has been developed. METHODS\ Aceton itrile-water (44∶56) was used as a mobile phase, while a Hypersil C 18 c olumn (5 μm, 200 mm×4.6 mm) as a stationary phase, and sildenafil was detected at 2 92 nm with flowing rate being rate 1 ml/min. RESULTS\ Sildenafil had a good line ar relation in the range of 20～80 μg/ml,the \%RSD\% was 1.27%, the average r ecov ery was 99.48% and the limit concentration was 0.1 μg/ml. CONCLUSION\ This method was simple, sensitive and rapid and it can be applied to the conten t determination of sildenafil tablets and related compound.