OBJECTIVE  To qualitative and quantitative analyze the fluvoxamine maleate tablets by nuclear magnetic resonance(NMR).

METHODS The ingredients of fluvoxamine maleate tablets were extracted by CDCl₃, spectra of ¹H-NMR, ¹³C-NMR, ¹⁹F-NMR and HSQC were determined. Fluorine spectrum peak at δ: −61.1×10⁻⁶− −60.9×10⁻⁶ of fluvoxamine maleate and δ: −122.8×10⁻⁶− −121.9×10⁻⁶ of NaF were employed as quantitative peaks and internal standard peaks, respectively. Quantitative ¹⁹F-NMR spectra(¹⁹F-qNMR) of the mixture were collected, and then calculated the content of fluvoxamine maleate tablets by comparing area of the two signal peaks. Method validation of ¹⁹F-qNMR was also accomplished.

RESULTS Nuclear magnetic resonance information of the extracted ingredients from fluvoxamine maleate tablets was the same as the structure of fluvoxamine maleate. The established ¹⁹F-qNMR method had characteristic of high specificity. There was a linear relationship for fluvoxamine maleate in the range of 10.54−30.69 mg·mL⁻¹. Its precision and stability were good, and the average recovery was 99.69%. Determination results of ¹⁹F-qNMR method were consistent with those of HPLC.

CONCLUSION NMR method can be used for qualitative and quantitative of fluvoxamine maleate tablets simultaneously, which provide a rapid and accurate research method for production and clinical drug monitoring.