Stability-indicating reversed-phase HPLC method development and characterization of impurities in vortioxetine utilizing LC-MS, IR and NMR

被引：16

作者：

Liu, Lei ^{[1
]}

Cao, Na ^{[1
]}

Ma, Xingling ^{[1
]}

Xiong, Kaihe ^{[2
]}

Sun, Lili ^{[2
]}

Zou, Qiaogen ^{[1
]}

Yao, Lili ^{[3
]}

机构：

[1] Nanjing Tech Univ, Sch Pharmaceut Sci, Nanjing 210009, Peoples R China

[2] Nanjing Tech Univ, Coll Biotechnol & Pharmaceut Engn, Nanjing 210009, Peoples R China

[3] Nanjing Tech Univ, Coll Food Sci & Light Ind, Nanjing 210009, Peoples R China

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2016年 / 117卷

关键词：

Vortioxetine; Process-related impurities; Quantification; Structural elucidation; LU AA21004;

D O I：

10.1016/j.jpba.2015.08.028

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The current study reports the development and validation of a stability-indicating reversed phase HPLC method for the separation and identification of potential impurities in vortioxetine, a recently developed antidepressant. The structures of a new compound and four process-related impurities formed during the synthesis were characterized and confirmed by NMR, MS, and IR spectroscopy analyses. The most probable formation mechanisms of the impurities identified were proposed. Based on the characterization data, the new compound was proposed to be 1-[4-[(2,4-dimethylphenyl)thio]phenyl]-piperazine. In addition, an efficient chromatographic method was optimized to separate and quantify the impurities, which were obtained in the 0.05-0.75 mu g/mL range. The developed HPLC method was validated with respect to accuracy, precision, linearity, robustness, and limits of detection and quantitation. (C) 2015 Published by Elsevier B.V.

引用

页码：325 / 332

页数：8

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