Analysis of Ambrisentan Tablets

Objective To develop a method for the determination of dissolution rate,content,related substances of ambrisentan tablets. Methods The determination was performed on Agilent ZORBAX-C18( 150 mm ×4. 6 mm,5 μm) column,and the mobile phase was 5 mmol·L- 1phosphate buffer( p H = 2. 5) and acetonitrile of45∶ 55 at a flow rate of 1. 0 ml·min- 1. The temperature of the column was 30 ℃ and the detection wavelength was263 nm. The detection wavelength of dissolution was changed to 213 nm,but other conditions were unchanged.Results The equation of linear regression was A = 18 673C- 27. 321,r = 0. 9993( n = 7),RSD of precision and stability was 0. 48% and 0. 78%,and the average recovery was 100. 15%( RSD = 1. 04%). For the analysis of dissolution,the equation of linear regression was A = 75. 48 C- 5. 73,r = 0. 9993( n = 8). RSD of precision and stability was 1. 12% and 1. 05%,while the average recovery was 99. 79%( RSD = 0. 79%). Conclusion This analytic method for ambrisentan is simple,accurate,specific and sensitive,so it can be used for quality evaluation of ambrisentan tablets.