摘要
目的：建立他达拉非片含量测定及有关物质检查的方法。方法：采用高效液相色谱法。色谱柱：安捷伦ZORBAX E-clipse XDB C8（250 mm ×4.6 mm,5μm）；流动相：0.1%三氟乙酸溶液-乙腈（65∶35）；流速：1.0 ml·min-1；柱温：35℃；检测波长：285 nm,进样量20μl。结果：在选定的色谱条件下,主成分与各杂质峰分离度良好。他达拉非质量浓度在20.13~201.30μg ·ml-1范围内与峰面积有良好的线性关系（r=0.9993）；平均回收率为99.5%（RSD=1.1%,n=9）；检出限为0.6 ng,定量限为2 ng。结论：该方法专属性强、灵敏度高,可用于他达拉非片含量和有关物质测定。
Objective：To establish a determination method for the content and related substances of tadalafil tablets. Methods：An HPLC method was adopted. The determination was performed on a ZORBAX Eclipse XDB C8 （250 mm × 4. 6 mm,5μm） column with the mobile phase consisting of 0.1% trifluoroacetic acid-acetonitrile（65∶35）at a flow rate of 1.0 ml· min-1,the column temperature was controlled at 35℃, the detection wavelength was 285 nm and the injection volume was 20 μl. Results：The related substances could be completely separated from the maln component under the selected chromatographic conditions. A good linear relationship was found be-tween the peak area and the concentration of tadalafil within the range of 20. 13-201. 30μg·ml-1（r=0. 999 3） with the average recover-y of 99. 5% （RSD=1. 1%, n= 9）. The limit of detection was 0. 6 ng and the limit of quantification was 2 ng. Conclusion：The method is specific and sensitive, and can be used in the determination of content and related substances of tadalafil tablets.
出处
《中国药师》
CAS
2015年第5期870-872,共3页
China Pharmacist
