Abstract:
1H quantitative nuclear magnetic resonance (
1H qNMR) is an easy, fast analytical method.This method was used to simultaneously determine both contents and ratio of tenofovir alafenamide and fumarate in salt-forming drugs tenofovir alafenamide fumarate (TAF).
1H NMR sample was prepared using deuterated dimethyl sulfoxide (DMSO-
d6) as solvent.Content of TAF and fumarate were calculated after comparison of peak integrations of sample with internal standard.A linear relationship was found between TAF and fumarate in the range of 0.91-1.24.Content of TAF and fumarate from
1H qNMR was estimated to be 100.06 % and 10.90 %, respectively.These data were consistent with the mass balance method.This
1H qNMR method provides accurate and rapid determination of ratio and absolute content of multi-component, salt-forming API.