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Development and Validation of a Method for Identification and Quantitative Determination of Residual Organic Solvents in the Drug Substance of a Dipeptide Mimetic of Nerve Growth Factor (Gk-2)

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Pharmaceutical Chemistry Journal Aims and scope

Anovel gas-chromatographic method with static headspace extraction was developed and validated for identifying and determining quantitatively residual organic solvents in the drug substance of an innovative dipeptide mimetic of nerve growth factor (GK-2). The developed chromatography conditions allowed effective separation of the chromatographic peaks for all organic solvents used to synthesize and purify the drug substance, i.e., MeOH, toluene, CH2Cl2 , Py, EtOH, Et2O, and trifluoroacetic acid. Validation of the method confirmed its specificity, linearity, accuracy, and precision.

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Authors and Affiliations

  1. V. V. Zakusov State Institute of Pharmacology, Russian Academy of Sciences, Moscow, Russia

    M. E. Dudenkova, L. N. Grushevskaya, M. S. Sergeeva, L. M. Gaevaya, E. D. Denisenko, S. V. Minaev & N. M. Sazonova

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  1. M. E. Dudenkova
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  2. L. N. Grushevskaya
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  3. M. S. Sergeeva
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  4. L. M. Gaevaya
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  5. E. D. Denisenko
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  6. S. V. Minaev
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  7. N. M. Sazonova
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Corresponding author

Correspondence to M. E. Dudenkova.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 2, pp. 49 – 53, February, 2020.

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Dudenkova, M.E., Grushevskaya, L.N., Sergeeva, M.S. et al. Development and Validation of a Method for Identification and Quantitative Determination of Residual Organic Solvents in the Drug Substance of a Dipeptide Mimetic of Nerve Growth Factor (Gk-2). Pharm Chem J 54, 195–200 (2020). https://doi.org/10.1007/s11094-020-02177-z

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  • DOI: https://doi.org/10.1007/s11094-020-02177-z

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