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Development of Chromatographic Methods for Assay of Contaminants of Russian-Made Tramadol Hydrochloride Substance

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Pharmaceutical Chemistry Journal Aims and scope

Methods for identifying contaminants in Russian-made tramadol hydrochloride substance were developed. Detection of the RS,SR-isomer in tramadol hydrochloride substance was by HPLC with UV detection. Identification of (2RS)[(dimethylamino)methyl]cyclohexanone was by chromatography in a thin layer of sorbent on Sorbfil F254 plates. The HPLC method was validated in terms of efficiency, linearity, and reproducibility. Detection sensitivity for contaminants was 0.0001 mg/cm3 (0.02%).

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Authors and Affiliations

  1. State Science Research Institute Organic Chemistry and Technology, Moscow, Russia

    U. A. Murashova, L. V. Skalkina, P. V. Kazakov & N. S. Mirzabekova

Authors
  1. U. A. Murashova
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  2. L. V. Skalkina
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  3. P. V. Kazakov
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  4. N. S. Mirzabekova
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Corresponding author

Correspondence to N. S. Mirzabekova.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 7, pp. 55 – 60, July, 2020.

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Murashova, U.A., Skalkina, L.V., Kazakov, P.V. et al. Development of Chromatographic Methods for Assay of Contaminants of Russian-Made Tramadol Hydrochloride Substance. Pharm Chem J 54, 766–771 (2020). https://doi.org/10.1007/s11094-020-02268-x

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  • DOI: https://doi.org/10.1007/s11094-020-02268-x

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