Synthesis and characterization of impurities of barnidipine hydrochloride, an antihypertensive drug substance

  • Molecules. 2014 Jan 21;19(1):1344-52. doi: 10.3390/molecules19011344.
Zhi-Gang Cheng  1 ,  Xu-Yong Dai  2 ,  Li-Wei Li  3 ,  Qiong Wan  4 ,  Xiang Ma  5 ,  Guang-Ya Xiang  6
Affiliations
  • 1. School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. [email protected].
  • 2. Wuhan Biocause Pharmaceutical Development Co., Ltd, Wuhan 430056, Hubei, China. [email protected].
  • 3. College of Chemical Engineering and Pharmacy, Jingchu University of Technology, Jingmen 448000, Hubei, China. [email protected].
  • 4. Hubei Biocause Heilen Pharmaceutical Co., Ltd, Jingmen 448000, Hubei, China. [email protected].
  • 5. School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. [email protected].
  • 6. School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. [email protected].
PMID: 24451253 DOI: 10.3390/molecules19011344
Abstract

Barnidipine hydrochloride is a long term dihydropyridine Calcium Channel blocker used for the treatment of hypertension. During the process development of barnidipine hydrochloride, four barnidipine impurities were detected by high-performance liquid chromatography (HPLC) with an ordinary column (Agilent ZORBAX Eclipse XDB-C18, 150 mm×4.6 mm, 5 µm). All these impurities were identified, synthesized, and subsequently characterized by their respective spectral data (MS, 1H-NMR, and 13C-NMR). The identification of these impurities should be useful for quality control in the manufacture of barnidipine.

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