AN LC–ESI-MS/MS METHOD DEVELOPMENTAND ITS VALIDATIONFOR THE QUANTIFICATION OF PRALSETINIB IN K2EDTA HUMANPLASMA

Authors

  • SUNIL DATTATRAY PAWAR Dr. Babasaheb Ambedkar Marathwada University Aurangabad, Department of Chemistry of S. B. E. S. Collage Aurangabad-431001, Maharashtra, India
  • DEEPAK D. KAYANDE Dr. Babasaheb Ambedkar Marathwada University Aurangabad, Department of Chemistry of S. B. E. S. Collage Aurangabad-431001, Maharashtra, India
  • KOKILA PAWAR Dr. Babasaheb Ambedkar Marathwada University Aurangabad, Department of Chemistry of S. B. E. S. Collage Aurangabad-431001, Maharashtra, India
  • MAZAHAR FAROOQUI Dr. Babasaheb Ambedkar Marathwada University Aurangabad, Department of Chemistry of S. B. E. S. Collage Aurangabad-431001, Maharashtra, India https://orcid.org/0000-0003-2236-6639
  • ANIL SHANKARWAR Dr. Babasaheb Ambedkar Marathwada University Aurangabad, Department of Chemistry of S. B. E. S. Collage Aurangabad-431001, Maharashtra, India
  • AMOL DESHPANDE Dr. Babasaheb Ambedkar Marathwada University Aurangabad, Department of Chemistry of S. B. E. S. Collage Aurangabad-431001, Maharashtra, India
  • SUNIL SHANKARWAR Dr. Babasaheb Ambedkar Marathwada University Aurangabad, Department of Chemistry of S. B. E. S. Collage Aurangabad-431001, Maharashtra, India https://orcid.org/0009-0005-7871-6062

DOI:

https://doi.org/10.22159/ijap.2025v17i5.53561

Keywords:

Pralsetinib, Cancer, LC-MS/MS, K2EDT aplasma, Validation

Abstract

Objective: Aim of the work is to developa simple LC-ESI-MS/MS approach for a sensitive, specific, and quantitative determination of pralsetinib in human K2EDTA plasma.

Methods: The samples were separated using an isocratic mobile phase made up of 0.1%HCOOH, methanol and acetonitrile in 10:70:20(% v/v) fractions. In multiple reaction monitoring mode, mass transitions for pralsetinib were m/z 534.27/302.19 and for asciminib internal standard, they were 450.1/257.10 in positive ionization mode.

Results: Linearity and a high r2 value (>0.99) characterize the calibration curve, which spans 141.5–5660 ng/ml. Theintra-batchaccuracywaswithin-8.44 to 5.69% relative errorandtheprecisionwaswithin3.14 to 4.92%. Theinter-batchaccuracywaswithin-5.26 to 4.63% relative error and the precision was within 3.32 to 4.93%. The extraction recoveries executed at three quality control levels and their mean recovery was 97.45%.

Conclusion: In conclusion, a new approach to evaluating pralsetinib in human K2EDTA plasma has been approved for use in clinical, bioavailability, and bioequivalence investigations, and it may be used to quantify pralsetinib.

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Published

07-09-2025

How to Cite

PAWAR, S. D., KAYANDE, D. D., PAWAR, K., FAROOQUI, M., SHANKARWAR, A., DESHPANDE, A., & SHANKARWAR, S. (2025). AN LC–ESI-MS/MS METHOD DEVELOPMENTAND ITS VALIDATIONFOR THE QUANTIFICATION OF PRALSETINIB IN K2EDTA HUMANPLASMA. International Journal of Applied Pharmaceutics, 17(5), 285–291. https://doi.org/10.22159/ijap.2025v17i5.53561

Issue

Vol 17, Issue 5 (Sep-Oct), 2025

Section

Original Article(s)

Copyright (c) 2025 SUNIL DATTATRAY PAWAR, DEEPAK D KAYANDE, KOKILA PAWAR, MAZAHAR FAROOQUI, ANIL SHANKARWAR, AMOL DESHPANDE, SUNIL SHANKARWAR

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

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