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
相关论文
共 50 条
  • [31] Isolation and Characterization of a Process Impurity in Tizanidine Hydrochloride
    Vijayakumar, E. K. S.
    Gore, V. G.
    Mahajan, A.
    Kumar, M.
    INDIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2010, 72 (03) : 360 - 362
  • [32] Identification and characterization of new impurity in didanosine
    Rao, D. V. N. Srinivasa
    Srinivas, N.
    Bharathi, Ch.
    Prasad, Ch. S.
    Dandala, Ramesh
    Naidu, A.
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2007, 45 (03) : 516 - 520
  • [33] Synthesis and characterization of polymethacrylamide having gabapentin moieties
    Akat, Hakan
    Balcan, Mehmet
    IRANIAN POLYMER JOURNAL, 2007, 16 (11) : 769 - 774
  • [34] Isolation and Characterization of an Unknown Process-Related Impurity in Furosemide and Validation of a New HPLC Method
    Xu, Ao
    Xue, Yunlin
    Zeng, Yuyu
    Li, Jing
    Zhou, Huiling
    Wang, Zhen
    Chen, Yin
    Chen, Hui
    Jin, Jian
    Zhuang, Tao
    MOLECULES, 2023, 28 (05):
  • [35] Identification, isolation and characterization of process-related impurities in Rizatriptan benzoate
    Raj, T. Joseph Sunder
    Bharathi, Ch.
    Kumar, M. Saravana
    Prabahar, Joseph
    Kumar, P. Naveen
    Sharma, Hemant Kumar
    Parikh, Kalpesh
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2009, 49 (01) : 156 - 162
  • [36] Isolation and identification of an unusual impurity in an intermediate of Rimadyl® (carprofen)
    Tucker, JL
    DeVries, KM
    Hammen, PD
    Rose, PR
    Raymer, BK
    Rescek, D
    HETEROCYCLES, 2003, 60 (07) : 1681 - 1688
  • [37] Identification and control of unspecified impurity in trimetazidine dihydrochloride tablet formulation
    Jefri
    Puspitasari, A. D.
    Talpaneni, J. S. R.
    Tjandrawinata, R. R.
    12TH JOINT CONFERENCE ON CHEMISTRY, 2018, 349
  • [38] ISOLATION AND IDENTIFICATION OF COMPONENTS OF A COMMERCIAL CHLORDANE FORMULATION
    SAHA, JG
    LEE, YW
    BULLETIN OF ENVIRONMENTAL CONTAMINATION AND TOXICOLOGY, 1969, 4 (05) : 285 - &
  • [39] Identification, Characterization, Synthesis and Quantification of Related Impurities of Liguzinediol
    Cheng, Dong
    Zhou, Ying
    Li, Wei
    Shan, Chen-Xiao
    Chai, Chuan
    Cui, Xiao-Bing
    Kang, Bi
    Wang, Tian-Lin
    Wen, Hong-Mei
    JOURNAL OF CHROMATOGRAPHIC SCIENCE, 2015, 53 (08) : 1280 - 1288
  • [40] Isolation, synthesis, identification of new process-related impurities in evocalcet
    Yan, Hongyi
    Wang, Yabo
    Yue, Yongli
    Li, Li
    Shi, Xiaowei
    Zhang, Kai
    Xue, Na
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2022, 214
12345