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Liquid Chromatography Tandem Mass Spectrometric Method for Quantification of Margetuximab in Rat Plasma and Application to a Pharmacokinetic Study

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Abstract

Margetuximab was approved for the treatment of advanced HER2+ breast cancer. A feasible analytical technique that can measure this drug was obligatory. In light of this, a novel and thoroughly validated liquid chromatographic (LC)-tandem mass spectrometric (MS/MS) approach was developed for the quantification of margetuximab in rat plasma. The liquid-liquid extraction method was used to extract the analyte from rat plasma. The analyte was separated using acetonitrile and formic acid buffer (30:70) as a mobile phase on Waters, alliance e-2695 model HPLC having Symmetry C18 column, 150 mm × 4.6 mm, 3.5-µm column. The overall runtime was 6 min at a flow rate of 1.0 ml/min. The method showed significant sensitivity and acceptable linearity over the concentration range of 6–120 ng/ml. Accuracy was within 98.51–99.92%. The intraday precision ranged between 0.41 and 8.98% CV. Also, the findings of pharmacokinetic parameters such as Cmax, tmax, AUC0–∞, AUC0–t, and half-life results of margetuximab showed that the technique was helpful for accurately measuring drug concentrations in rat plasma. The method that was developed was useful and effective for quantifying margetuximab.

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Acknowledgements

The authors are thankful to the management of GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, India, for providing necessary facilities and M.V.V.S Murthi fellowship grants to carry out the research work.

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Authors and Affiliations

  1. Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, 530 045, Andhra Pradesh, India

    Pridhvi Krishna Gaddey & Raja Sundararajan

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  1. Pridhvi Krishna Gaddey
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  2. Raja Sundararajan
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Contributions

Pridhvi Krishna Gaddey: methodology, validation, formal analysis, investigation, conceptualisation, writing—original draft, writing—review and editing; Raja Sundararajan: methodology, supervision.

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Correspondence to Raja Sundararajan.

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Ethical Declaration

All procedures involving animals were in compliance with the CPCSEA guidelines and ethical approval was granted by the Institute of Animals Ethics Committee (Reg. No. 1250/PO/RcBi/S/09/CPCSEA).

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The authors declare no competing interests.

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Gaddey, P.K., Sundararajan, R. Liquid Chromatography Tandem Mass Spectrometric Method for Quantification of Margetuximab in Rat Plasma and Application to a Pharmacokinetic Study. AAPS PharmSciTech 25, 33 (2024). https://doi.org/10.1208/s12249-024-02755-4

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