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Study of Dolutegravir Degradation and Spectroscopic Identification of Products by LCMS, 1H and 13C NMR Techniques

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Pharmaceutical Chemistry Journal Aims and scope

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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The authors declare no conflict of interest.

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Authors and Affiliations

  1. Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, 522019, India

    T. N. V. Ganesh Kumar, S. Vidyadhara & N. Soundarya

  2. Indian Institute of Integrative Medicine, Mumbai, Maharashtra, India

    Niteen A. Narkhede

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  1. T. N. V. Ganesh Kumar
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  2. S. Vidyadhara
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  3. Niteen A. Narkhede
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  4. N. Soundarya
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Correspondence to T. N. V. Ganesh Kumar.

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Kumar, T.N.V.G., Vidyadhara, S., Narkhede, N.A. et al. Study of Dolutegravir Degradation and Spectroscopic Identification of Products by LCMS, 1H and 13C NMR Techniques. Pharm Chem J 53, 368–375 (2019). https://doi.org/10.1007/s11094-019-02007-x

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  • DOI: https://doi.org/10.1007/s11094-019-02007-x

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