Synthesis and characterization of impurities of barnidipine hydrochloride, an antihypertensive drug substance.
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.
School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. daixuyong111@126.com.
Zhi-Gang
ZG
Cheng
Wuhan Biocause Pharmaceutical Development Co., Ltd, Wuhan 430056, Hubei, China. daixuyong111@126.com.
Xu-Yong
XY
Dai
College of Chemical Engineering and Pharmacy, Jingchu University of Technology, Jingmen 448000, Hubei, China. jmliliwei@163.com.
Li-Wei
LW
Li
Hubei Biocause Heilen Pharmaceutical Co., Ltd, Jingmen 448000, Hubei, China. wanqiong@biocause.net.
Qiong
Q
Wan
School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. maxwellcn@yahoo.com.
Xiang
X
Ma
School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. champion88@163.com.
Guang-Ya
GY
Xiang
D000959:Antihypertensive Agents / Q000138:chemical synthesis* / Q000494:pharmacology*; D002121:Calcium Channel Blockers / Q000737:chemistry / Q000494:pharmacology; D004340:Drug Contamination; D015394:Molecular Structure; D009543:Nifedipine / Q000031:analogs & derivatives* / Q000138:chemical synthesis / Q000494:pharmacology; D019906:Nuclear Magnetic Resonance, Biomolecular
D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; C050699:mepirodipine; D009543:Nifedipine