Study of Dolutegravir Degradation and Spectroscopic Identification of Products by LCMS, 1H and 13C NMR Techniques
- Authors: Kumar T.N.1, Vidyadhara S.1, Narkhede N.A.2, Soundarya N.1
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Affiliations:
- Chebrolu Hanumaiah Institute of Pharmaceutical Sciences
- Indian Institute of Integrative Medicine
- Issue: Vol 53, No 4 (2019)
- Pages: 368-375
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245767
- DOI: https://doi.org/10.1007/s11094-019-02007-x
- ID: 245767
Cite item
Abstract
Stability study for dolutegravir bulk drug was performed and the degradation products formed were identified by chromatography (HPLC, LCMS) and spectroscopy (ESI-MS, FTIR, 1H and 13C NMR) techniques. Degradation of the drug in acidic and peroxide environment yielded one common major degradant f ((2,4-difluorophenyl) methanamine) with a mass peak at m/z = 182.44. In addition to this, five more minor degradation products (a, b, c, d and e) were formed. The structure interpretation showed that the drug degraded to its synthetic precursor and no extra structures were formed. Hence, it was suggested that drug dolutegravir should be kept away from acidic and oxygen rich conditions.
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About the authors
T. N. V. Ganesh Kumar
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences
Author for correspondence.
Email: ganeshtnv@gmail.com
India, Guntur, Andhra Pradesh, 522019
S. Vidyadhara
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences
Email: ganeshtnv@gmail.com
India, Guntur, Andhra Pradesh, 522019
Niteen A. Narkhede
Indian Institute of Integrative Medicine
Email: ganeshtnv@gmail.com
India, Mumbai, Maharashtra
N. Soundarya
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences
Email: ganeshtnv@gmail.com
India, Guntur, Andhra Pradesh, 522019