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Development and Validation of a Gas-Chromatographic Method for Quantitative Determination of Phenol in Biologicals

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

A gas-chromatographic method for quantitative determination of phenol in biological drugs was developed. The optimal chromatography conditions were a DB-WAX column (30 m × 0.25 mm × 0.25 μm, Agilent Technologies); injector temperature 250°C; split ratio 40:1; sample volume 0.5 μL; He carrier gas; constant pressure mode; flow rate 1.4 mL/min; furnace temperature profile: initial 160°C (constant for 3 min), ramp at 40°C/min to 200°C (constant for 0.6 min), ramp at 40°C/min to 220°C; analysis time 7.133 min; and detector temperature 250°C. The method was validated. The analytical range of the method was phenol concentrations from 1 to 5 mg/mL. The accuracy and specificity of the method were confirmed. The precision was evaluated. The results allowed this method to be considered an alternative for quantitative determination of phenol in biologicals.

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Authors and Affiliations

  1. Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051, Russia

    O. N. Kolesnikova, O. B. Runova & O. B. Ustinnikova

Authors
  1. O. N. Kolesnikova
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  2. O. B. Runova
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  3. O. B. Ustinnikova
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Corresponding author

Correspondence to O. N. Kolesnikova.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 52, No. 5, pp. 60 – 64, May, 2018.

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Kolesnikova, O.N., Runova, O.B. & Ustinnikova, O.B. Development and Validation of a Gas-Chromatographic Method for Quantitative Determination of Phenol in Biologicals. Pharm Chem J 52, 478–482 (2018). https://doi.org/10.1007/s11094-018-1843-0

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  • DOI: https://doi.org/10.1007/s11094-018-1843-0

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