Determination of Ambrisentan Reference Substance by 1 H-Nuclear Magnetic Resonance Spectroscopy
- VernacularTitle:核磁共振波谱法测定安立生坦对照品的含量
- Author:
Yan ZHONG
;
Baolai CHEN
;
Jiachun LI
;
Wenzhe HUANG
;
Zhenzhong WANG
;
Wei XIAO
- Publication Type:Journal Article
- Keywords:
1 H NMR;
Internal standard method;
Ambrisentan;
Content determination
- From:
China Pharmacist
2015;(5):750-752
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop a method for the quantitative determination of ambrisentan. Methods: 1 H NMR spectra were obtalned with a Bruker AscendTM 400 superconducting NMR spectrometer. For each sample, DMSO-D6 was used as the solvent, the pulse width was 10. 0 μs, the delay time was 5 s and the scanning time was 16. Results: The proton peaks of ambrisentan at δ6. 16 ppm and maleic acid atδ6. 28 ppm were used as the quantitative peaks. The linear regression equation of peak area and quality ratio was Y=0. 140 7X+0. 034 8 with the correlation coefficient of 0. 999 4. RSD was 0. 2%(n=6)in the repeated experiments. The absolute content of ambrisentan reference substance was 99. 9%. Conclusion: The results showed that 1 H NMR can be used in the quantitative determination of ambrisentan without reference substance. The method is reliable, rapid, accurate and simple.