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. 2016 Sep 10:129:509-513.
doi: 10.1016/j.jpba.2016.07.035. Epub 2016 Jul 21.

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

R Buchi Reddy  1 , Kishor R More  2 , Mukesh S Jha  1 , Brajesh Sharma  1 , Laki Magar  1
Affiliations

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

R Buchi Reddy et al. J Pharm Biomed Anal. .

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.

Keywords: Amadori rearrangement; Gabapentin; LC/MS/MS; Lactose; Maillard reaction; Structural elucidation.

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