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Development and Validation of a New Reverse Phase Ultra Performance Liquid Chromatography Method for the Estimation of Related Substances of the Anticancer Drug Zanubrutinib and Characterization of its Degradants Using Liquid Chromatography Mass Spectrometry

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Pharmaceutical Chemistry Journal Aims and scope

A new reverse phase ultra performance liquid chromatography method was developed and validated for the separation and analysis of impurities and zanubrutinib degradation products were characterized using liquid chromatography mass spectrometry. The chromatographic method was optimized using specimens generated by stress degradation and impurities spiked with the sample solution. On a 150 × 4.6 mm X-Bridge C18 column with a particle size of 3.5 µm connected to a PDA detector, and by using a linear mobile phase gradient prepared from trifluoroacetic acid (0.1%) in water and acetonitrile, with a flow rate of 1.0 mL/min and detection at 216 nm, good resolution of the analyte peak was obtained from peaks belonging to impurities and degradation products. Excellent accuracy, precision, and linearity results were obtained for zanubrutinbin and its impurities. When the forced test solutions were analyzed by comparison with the zanubrutinib working standard the mass balance was always close to 99.4%, indicating that the method was well stabilized and validation was performed under International Council for Harmonization requirements. Limit of detection and limit of quantification were well established, and the correlation coefficient of zanubrutinib and related compounds was 0.999.

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Authors and Affiliations

  1. Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, AP, India, 522510

    Subrahmanyam Talari & K. Chandra Mohan

  2. Department of Chemistry, Vignan Degree College, Guntur, AP, India, 522009

    Anuradha Vejendla

  3. Department of Chemistry, Adikavi Nannaya University, Rajamahendravaram, AP, India, 533296

    K. Deepthi

  4. Department of Chemistry, Sir CR Reddy College, Eluru, AP, India, 534007

    Subrahmanyam Talari & G. R. Satyanarayana

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  1. Subrahmanyam Talari
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Correspondence to Anuradha Vejendla.

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Talari, S., Vejendla, A., Deepthi, K. et al. Development and Validation of a New Reverse Phase Ultra Performance Liquid Chromatography Method for the Estimation of Related Substances of the Anticancer Drug Zanubrutinib and Characterization of its Degradants Using Liquid Chromatography Mass Spectrometry. Pharm Chem J 57, 1118–1129 (2023). https://doi.org/10.1007/s11094-023-02992-0

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  • DOI: https://doi.org/10.1007/s11094-023-02992-0

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