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Development of the Conditions for Direct Quantitative Determination of Amino Acids in Biologics by Hydrophilic Interaction HPLC

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Pharmaceutical Chemistry Journal Aims and scope

An analytical method for direct determination of amino acids (methionine, proline, glycine, histidine, arginine, and lysine) in biologics by hydrophilic interaction HPLC with UV detection was developed. Sample preparation was carried out by solid-phase extraction. HPLC separation used an SeQuant ZIC-HILIC column (250 × 4.6 mm, 5 μm) in isocratic mode and a mobile phase consisting of MeCN and ammonium formate (20 mM) at pH 3.3 (65:35, v/v) and flow rate 0.8 mL/min. UV detection was made at 198 nm. The procedure was validated for specificity, precision, linearity, and accuracy. The developed chromatographic method can be used as an alternative for quantitative determination of amino acids in biologics. The advantages of this method are simplification of the sample-preparation stage by eliminating the derivatization stage and the ability for simultaneous selective quantitative determination of several amino acids.

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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. B. Runova, M. G. Korotkov & O. B. Ustinnikova

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  1. O. B. Runova
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  2. M. G. Korotkov
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  3. O. B. Ustinnikova
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Correspondence to O. B. Runova.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 55, No. 6, pp. 53 – 58, June, 2021.

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Runova, O.B., Korotkov, M.G. & Ustinnikova, O.B. Development of the Conditions for Direct Quantitative Determination of Amino Acids in Biologics by Hydrophilic Interaction HPLC. Pharm Chem J 55, 621–626 (2021). https://doi.org/10.1007/s11094-021-02467-0

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  • DOI: https://doi.org/10.1007/s11094-021-02467-0

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