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Article

Development of Improved High-Performance Liquid Chromatography Method for the Determination of Residual Caprylic Acid in Formulations of Human Immunoglobulins

1
Centre for Research and Knowledge Transfer in Biotechnology, University of Zagreb, Rockefellerova 10, 10000 Zagreb, Croatia
2
Institute of Immunology, Inc., Rockefellerova 10, 10000 Zagreb, Croatia
*
Authors to whom correspondence should be addressed.
Academic Editor: Alexis Oliva
Molecules 2022, 27(5), 1665; https://doi.org/10.3390/molecules27051665
Received: 11 February 2022 / Revised: 28 February 2022 / Accepted: 1 March 2022 / Published: 3 March 2022
Quality control of human immunoglobulin formulations produced by caprylic acid precipitation necessitates a simple, rapid, and accurate method for determination of residual caprylic acid. A high-performance liquid chromatography method for that purpose was developed and validated. The method involves depletion of immunoglobulins, the major interfering components that produce high background noise, by precipitation with acetonitrile (1:1, v/v). Chromatographic analysis of caprylic acid, preserved in supernatant with no loss, was performed using a reverse-phase C18 column (2.1 × 150 mm, 3 μm) as a stationary phase and water with 0.05% TFA–acetonitrile (50:50, v/v) as a mobile phase at a flow rate of 0.2 mL/min and run time of 10 min. The developed method was successfully validated according to the ICH guidelines. The validation parameters confirmed that method was linear, accurate, precise, specific, and able to provide excellent separation of peaks corresponding to caprylic acid and the fraction of remaining immunoglobulins. Furthermore, a 24−1 fractional factorial design was applied in order to test the robustness of developed method. As such, the method is highly suitable for the quantification of residual caprylic acid in formulations of human immunoglobulins for therapeutic use, as demonstrated on samples produced by fractionation of convalescent anti-SARS-CoV-2 human plasma at a laboratory scale. The obtained results confirmed that the method is convenient for routine quality control. View Full-Text
Keywords: caprylic acid; high-performance liquid chromatography method; convalescent anti-SARS-CoV-2 human plasma; human immunoglobulins; validation; quality control caprylic acid; high-performance liquid chromatography method; convalescent anti-SARS-CoV-2 human plasma; human immunoglobulins; validation; quality control
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MDPI and ACS Style

Štimac, A.; Kurtović, T.; Pavlović, N.; Halassy, B. Development of Improved High-Performance Liquid Chromatography Method for the Determination of Residual Caprylic Acid in Formulations of Human Immunoglobulins. Molecules 2022, 27, 1665. https://doi.org/10.3390/molecules27051665

AMA Style

Štimac A, Kurtović T, Pavlović N, Halassy B. Development of Improved High-Performance Liquid Chromatography Method for the Determination of Residual Caprylic Acid in Formulations of Human Immunoglobulins. Molecules. 2022; 27(5):1665. https://doi.org/10.3390/molecules27051665

Chicago/Turabian Style

Štimac, Adela, Tihana Kurtović, Nediljko Pavlović, and Beata Halassy. 2022. "Development of Improved High-Performance Liquid Chromatography Method for the Determination of Residual Caprylic Acid in Formulations of Human Immunoglobulins" Molecules 27, no. 5: 1665. https://doi.org/10.3390/molecules27051665

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