Identification, synthesis, isolation and characterization of formulation related impurity of Gabapentin

被引：6
|
作者：
Reddy, R. Buchi [1 ]
More, Kishor R. [1 ]
Jha, Mukesh S. [1 ]
Sharma, Brajesh [1 ]
Magar, Laki [1 ]
机构：
[1] Ipca Labs Ltd, Div Chem Res, Kandivli Ind Estate, Bombay 400067, Maharashtra, India
来源：
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2016年 / 129卷
关键词：
Gabapentin; Lactose; Amadori rearrangement; Maillard reaction; LC/MS/MS; Structural elucidation;
D O I：
10.1016/j.jpba.2016.07.035
中图分类号：
O65 [分析化学];
学科分类号：
070302 ; 081704 ;
摘要：
An unknown impurity was observed during stability studies of Gabapentin capsules. This impurity has been identified, synthesized, isolated and characterized using modern analytical tool. The novel impurity was confirmed as adduct of Gabapentin and lactose: an excipient used in formulation. The elucidated impurity was further confirmed by its synthesis, which was formed due to Maillard reaction and Amadori rearrangement. (C) 2016 Published by Elsevier B.V.
引用
收藏
页码：509 / 513
页数：5
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