1. Academic Validation
  2. Synthesis and characterization of impurities of barnidipine hydrochloride, an antihypertensive drug substance

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

Affiliations

  • 1 School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. daixuyong111@126.com.
  • 2 Wuhan Biocause Pharmaceutical Development Co., Ltd, Wuhan 430056, Hubei, China. daixuyong111@126.com.
  • 3 College of Chemical Engineering and Pharmacy, Jingchu University of Technology, Jingmen 448000, Hubei, China. jmliliwei@163.com.
  • 4 Hubei Biocause Heilen Pharmaceutical Co., Ltd, Jingmen 448000, Hubei, China. wanqiong@biocause.net.
  • 5 School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. maxwellcn@yahoo.com.
  • 6 School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. champion88@163.com.
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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