title: Identification, synthesis, isolation and characterization of formulation related impurity of Gabapentin.
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.
authors: Ipca Laboratories Ltd., Chemical Research Division, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India.
authors: R Buchi
authors: RB
authors: Reddy
authors: Ipca Laboratories Ltd., Chemical Research Division, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India. Electronic address: kishor.more@ipca.com.
authors: Kishor R
authors: KR
authors: More
authors: Ipca Laboratories Ltd., Chemical Research Division, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India.
authors: Mukesh S
authors: MS
authors: Jha
authors: Ipca Laboratories Ltd., Chemical Research Division, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India.
authors: Brajesh
authors: B
authors: Sharma
authors: Ipca Laboratories Ltd., Chemical Research Division, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India.
authors: Laki
authors: L
authors: Magar
mesh_terms: D000588:Amines / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D003509:Cyclohexanecarboxylic Acids / Q000737:chemistry*; D004340:Drug Contamination; D005079:Excipients / Q000737:chemistry; D000077206:Gabapentin; D007785:Lactose / Q000737:chemistry; D015416:Maillard Reaction; D005680:gamma-Aminobutyric Acid / Q000737:chemistry*
chemical_list: D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D005079:Excipients; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D007785:Lactose
keywords: Amadori rearrangement; Gabapentin; LC/MS/MS; Lactose; Maillard reaction; Structural elucidation