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加巴喷丁制剂相关杂质的鉴定、合成、分离与表征

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

作者信息

Reddy R Buchi, More Kishor R, Jha Mukesh S, Sharma Brajesh, Magar Laki

机构信息

Ipca Laboratories Ltd., Chemical Research Division, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India.

Ipca Laboratories Ltd., Chemical Research Division, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India.

出版信息

J Pharm Biomed Anal. 2016 Sep 10;129:509-513. doi: 10.1016/j.jpba.2016.07.035. Epub 2016 Jul 21.

DOI:10.1016/j.jpba.2016.07.035
PMID:27497652
Abstract

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.

摘要

加巴喷丁胶囊稳定性研究期间观察到一种未知杂质。已使用现代分析工具对该杂质进行了鉴定、合成、分离和表征。该新型杂质被确认为加巴喷丁与乳糖（制剂中使用的一种辅料）的加合物。通过合成进一步证实了所阐明的杂质，其是由美拉德反应和阿马多里重排形成的。

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