Determination of Content and Related Substances of Tadalafil Tablets by HPLC
- VernacularTitle:HPLC法测定他达拉非片含量和有关物质
- Author:
Xinghui GUO
- Publication Type:Journal Article
- Keywords:
HPLC;
Tadalafil tablets;
Content;
Related substances
- From:
China Pharmacist
2015;(5):870-872
- CountryChina
- Language:Chinese
-
Abstract:
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.
