通过制备型高效液相色谱（HPLC），随后结合质谱-质谱联用（MS-MS）和二维核磁共振光谱（2D-NMR）对盐酸非那吡啶一种潜在的工艺相关杂质进行分离与表征。
Isolation and characterization of a potential process related impurity of phenazopyridine HCl by preparative HPLC followed by MS-MS and 2D-NMR spectroscopy.
作者信息
Rao R Nageswara, Maurya Pawan K, Raju A Narasa
机构信息
Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Tarnaka, Hyderabad 500607, India.
出版信息
J Pharm Biomed Anal. 2009 Jul 12;49(5):1287-91. doi: 10.1016/j.jpba.2009.03.004. Epub 2009 Mar 20.
During the process development of phenazopyridine HCl bulk drug, a potential impurity was detected in the routine impurity profiles by HPLC. Using MS-MS and multidimensional NMR techniques, the trace level impurity was unambiguously identified to be 3-phenyl-5-phenylazo-pyridine-2,6-diamine after its isolation from phenazopyridine HCl by semi-preparative HPLC. The formation of the impurity was discussed. To our knowledge, it is a novel impurity not reported elsewhere.
在盐酸非那吡啶原料药的工艺开发过程中，通过高效液相色谱法（HPLC）在常规杂质谱中检测到一种潜在杂质。使用串联质谱（MS-MS）和多维核磁共振（NMR）技术，通过半制备高效液相色谱法从盐酸非那吡啶中分离出痕量水平的杂质后，明确鉴定其为3-苯基-5-苯偶氮基吡啶-2,6-二胺。讨论了该杂质的形成。据我们所知，这是一种在其他地方未报道过的新型杂质。
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