title: Synthesis and Characterization of Process-Related Impurities of Antidiabetic Drug Linagliptin.
abstract: Linagliptin, a xanthine derivative, is a highly potent, selective, long-acting and orally bioavailable DPP-4 inhibitor for the treatment of type 2 diabetes. During the process development of linagliptin, five new process-related impurities were detected by high performance liquid chromatography (HPLC). All these impurities were identified, synthesized, and subsequently characterized by their respective spectral data (MS, HRMS, ¹H-NMR, (13)C-NMR and IR) as described in this article. The identification of these impurities should be useful for quality control and the validation of the analytical method in the manufacture of linagliptin.
authors: Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, 285 Gebaini Road, Pudong, Shanghai 201203, China. cpuhyw2010@163.com.
authors: Yiwen
authors: Y
authors: Huang
authors: Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, 285 Gebaini Road, Pudong, Shanghai 201203, China. xuesitu@163.com.
authors: Xiaoqing
authors: X
authors: He
authors: Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, 285 Gebaini Road, Pudong, Shanghai 201203, China. wu.taizhi@sipi.com.cn.
authors: Taizhi
authors: T
authors: Wu
authors: Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, 285 Gebaini Road, Pudong, Shanghai 201203, China. zhangfuli1@sinopharm.com.
authors: Fuli
authors: F
authors: Zhang
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D006801:Humans; D007004:Hypoglycemic Agents / Q000138:chemical synthesis* / Q000737:chemistry* / Q000627:therapeutic use; D000069476:Linagliptin / Q000138:chemical synthesis* / Q000737:chemistry* / Q000627:therapeutic use
chemical_list: D007004:Hypoglycemic Agents; D000069476:Linagliptin
keywords: characterization; impurities; linagliptin; synthesis; type 2 diabetes