OBJECTIVE To establish the first batch of national reference standard for quantitative and qualitative analysis of vor-tioxetine hydrobromide.METHODS The structure of vortioxetine hydrobromide was identified by means of 1H-NMR,13C-NMR,MS,IR and UV.HPLC purity was calculated via peak area normalization and principal component self-comparison.The homogeneity and stability were studied by HPLC,and other physicochemical properties were investigated using various analytical methods.The con-tent was determined using mass balance method and verified by NMR quantitative method and differential scanning calorimetry.RESULTS The structure of the first batch of national reference substance of vortioxetine hydrobromide was confirmed and its content was determined to be 99.9％.CONCLUSION The development of the first batch of national reference substance of vortioxetine hydrobromide can meet the quality control requirements of raw material and preparations of vortioxetine hydrobromide.
关键词
氢溴酸伏硫西汀/对照品/结构确证/质量平衡法/核磁共振定量
Key words
vortioxetine hydrobromide/reference standard/structure confirmation/mass balance method/quantitative nuclear magnetic resonance
维普
万方数据