Isolation and characterization of a potential process related impurity of phenazopyridine HCl by preparative HPLC followed by MS-MS and 2D-NMR spectroscopy

被引：11

作者：

Rao, R. Nageswara ^{[1
]}

Maurya, Pawan K. ^{[1
]}

Raju, A. Narasa ^{[1
]}

机构：

[1] Indian Inst Chem Technol, Discovery Lab, Div Analyt Chem, Hyderabad 500607, Andhra Pradesh, India

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2009年 / 49卷 / 05期

关键词：

Phenazopyridine HCl; Impurity profile; Semi-preparative HPLC; ESI-MS/MS; 2D-NMR; DERIVATIVE SPECTROPHOTOMETRY; HYDROCHLORIDE; NITROFURANTOIN; TABLETS;

D O I：

10.1016/j.jpba.2009.03.004

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

During the process development of phenazopyridine HCl bulk drug. a potential impurity was detected it) 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. (C) 2009 Published by Elsevier B.V.

引用

页码：1287 / 1291

页数：5