Qualitative and Quantitative Analysis of Fluvoxamine Maleate Tablets Based on Nuclear Magnetic Resonance

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.