A method for determination of related impurities in the new anxiolytic drug substance GML-3 was developed. HPLC and TLC techniques that could identify starting materials and synthetic intermediates and quantify them and unidentified impurities with contents of 0.05% and less in the drug substance were developed. The proposed techniques could be used further for quality control of GML-3 drug substance.
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References
S. B. Seredenin, G. V. Mokrov, et al., RU Pat. 2,572,076 C2, Dec. 27, 2015; Byull. Izobret., No. 36 (2015).
M. A. Yarkova, P. Yu. Povarnina, G. V. Mokrov, et al., Eksp. Klin. Farmakol., No. 4, 3 – 7 (2017).
G. V. Mokrov, O. A. Deeva, T. A. Gudasheva, et al., Bioorg. Med. Chem., No. 23, 3368 – 3378 (2015).
L. M. Gaevaya, L. N. Grushevskaya, M. S. Sergeeva, et al., Pharm. Chem. J., 52(9), 790 – 795 (2018).
M. S. Sergeeva, L. N. Grushevskaya, L. M. Gaevaya, et al., Biofarm. Zh., 11(4), 61 – 66 (2019).
GPM. 1.1.0012.15. Validation of analytical methods, State Pharmacopoeia of the Russian Federation, XIVth Ed., Vol. 1, (2018), pp. 276 – 288.
GPM. 1.1.0013.15. Statistical processing of chemical experiment results, State Pharmacopoeia of the Russian Federation, XIVth Ed., Vol. 1 (2018), pp. 289 – 318.
V. V. Beregovykh, Validation of analytical methods for drug manufacturers: Typical manufacturing guideline for drug production, Literra, Moscow (2008).
GPM. 1.1.0006.15. Drug substances, State Pharmacopoeia of the Russian Federation, XIVth Ed., Vol. 1 (2018), pp. 176 – 184.
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 8, pp. 40 – 46, August, 2020.
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Grushevskaya, L.N., Sergeeva, M.S., Gaevaya, L.M. et al. Development of a Method for Determination of Related Impurities in GML-3 Drug Substance: A New Compound with Anxiolytic Properties. Pharm Chem J 54, 838–845 (2020). https://doi.org/10.1007/s11094-020-02284-x
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DOI: https://doi.org/10.1007/s11094-020-02284-x