摘要
目的 :建立用 RP-HPLC法进行枸橼酸西地那非有关物质检查及其片剂的含量测定方法。方法 :采用 Hypersil ODS2柱 ,以乙腈 -0 .0 1 5 mol/L三乙胺水溶液 (用磷酸调 p H至 6 .0 ) ( 5 8∶ 4 2 )为流动相 ,流速 1 ml/min;检测波长 2 92 nm。结果 :在选定的色谱条件下 ,有关物质与主药分离良好 ,枸橼酸西地那非在 1 0~ 2 0 0μg/ml范围内 ,浓度与峰面积线性关系良好 ,平均回收率 :99.4 7% ,RSD=2 .0 %。结论 :本法可用于枸橼酸西地那非有关物质的检查及片剂的含量测定。
AIM The purpose is to establish a method for isolation of related compounds and determination of sildenafil citrate tablets. METHODS RP-HPLC is adopted using ODS column, the mobile phase is acetonitrile-0.015 mol/L triethylamine solution(use phosphase to adjust its pH of 6.0)(58∶42), and its mobile rate is 1ml/min. The detective wavelength is 292 nm. RESULTS Under the used chromatographic condition, the related compounds and sildenafil citrate can be completely separated. In the concentration range of 10~200 μg/ml, sildenafil citrate has fine linear responses. The average recovery is 99.47%, and the RSD is 2.0%(n=9). CONCLUSIONS This method had the advantage of simplicity and accuracy and can be used in quanlity control of sildenafil citrate.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2001年第6期429-431,共3页
Journal of China Pharmaceutical University