Determination of Related Substances of Vortioxetine Hydrobromide by HPLC / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish an HPLC method to determine the related substances of vortioxetine hydrobromide and identify the degradation products of vortioxetine hydrobromide by HPLC-MS. METHODS: An HPLC method was developed by using a CN column(Agilent Zorbax SB-CN, 4.6 mm × 250 mm, 5 μm), the mobile phase consisted of CH3CN-HCOONH4 (5050, pH adjusted to 5.0 with phosphoric acid), the flow rate was 1.0 mL•min -1, and the detection wavelength was set at 228 nm. The column temperature was maintained at 25 ℃, and the injection volume was 20 μL. RESULTS: Vortioxetine hydrobromide was well separated from the related substances. The detection sensitivity of vortioxetine hydrobromide and its related substances met the determination requirements. The calibration curves of vortioxetine hydrobromide and related substances had good linearity. The repeatability of the method was good(RSD = 6.89%, n = 6). The average recoveries of the sample were all within 95% - 105%. The degradation product produced by oxidation was identified by mass spectrometry as related substance D. CONCLUSION: The developed method proves to be simple, accurate, specific and reliable. It can be applied to the determination of vortioxetine hydrobromide and its related substances.