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ZJUS-B
Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology)  2006, Vol. 7 Issue (4): 310-313    DOI: 10.1631/jzus.2006.B0310
Materials, Chemistry & Chemical Engineering     
Characterization of a novel impurity in bulk drug of lisinopril by multidimensional NMR technique
Wang Dan-Hua, Pei Sai-Feng, Zhou Ming-Hua, Sun Cui-Rong, Pan Yuan-Jiang
Department of Chemistry, Zhejiang University, Hangzhou 310027, China; Zhejiang Huahai Pharmaceutical Co., Ltd., Linhai 317024, China
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Abstract  During the routine impurity profile of lisinopril bulk drug by HPLC (high-performance liquid chromatography), a potential impurity was detected. Using multidimensional NMR (nuclear magnetic resonance) technique, the trace-level impurity was unambiguously identified to be 2-(-2-oxo-azocan-3-ylamino)-4-phenyl-butyric acid after isolation from lisinopril bulk drug by semi-preparative HPLC. Formation of the impurity was also discussed. To our knowledge, this is a novel impurity and not reported elsewhere.

Key words： Lisinopril      Impurity      Structural characterization      NMR     
Received: 15 September 2005     
CLC:  O65  
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Wang Dan-Hua
Pei Sai-Feng
Zhou Ming-Hua
Sun Cui-Rong
Pan Yuan-Jiang
Cite this article:

Wang Dan-Hua, Pei Sai-Feng, Zhou Ming-Hua, Sun Cui-Rong, Pan Yuan-Jiang. Characterization of a novel impurity in bulk drug of lisinopril by multidimensional NMR technique. Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology), 2006, 7(4): 310-313.

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http://www.zjujournals.com/xueshu/zjus-b/10.1631/jzus.2006.B0310     OR     http://www.zjujournals.com/xueshu/zjus-b/Y2006/V7/I4/310

[1] Pei-xi ZHU, Dan-hua WANG, Cui-rong SUN, Zhi-quan SHEN. Characterization of impurities in the bulk drug lisinopril by liquid chromatography/ion trap spectrometry[J]. Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology), 2008, 9(5): 385-390.
[2] HU He-jiao, WANG Kui-wu, WU Bin, SUN Cui-rong, PAN Yuan-jiang. Chemical shift assignments of two oleanane triterpenes from Euonymus hederaceus[J]. Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology), 2005, 6( 8): 3-.