Development and Validation of RP-HPLC Method for Determination of Pirtobrutinib in Bulk and Pharmaceutical Dosage Form

Authors

  • P. Ravi Sankar, V. Ujwala , P. Srihari Prasad , J. Jhansi Rani , B. Swathi , N. Paparao , B. Divya , P. Srinivasa Babu Author

DOI:

https://doi.org/10.48047/hmmnms82

Keywords:

HPLC, Pirtobrutinib, ICH guidelines, Degradation studies.

Abstract

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (HPLC) method has been developed for the quantitative analysis of Pirtobrutinib in pharmaceutical dosage form. Chromatographic separation of Pirtobrutinib was achieved on Waters alliance e-2695 HPLC, by using Inertsil ODS (150 x 4.6 mm, 3.5 µ) column and the mobile phase containing 1.8 gms HSA is dissolved in 1lt of HPLC water pH-2.5/OPA & ACN in the ratio of 60:40 % v/v. The flow rate was 1.0 mL/min; detection was carried out by absorption at 271nm using a photodiode array detector at ambient temperature.

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References

Mato, A. R., Shah, N. N., Jurczak, W., Cheah, C. Y., Pagel, J. M., Woyach, J. A., ... & Wang, M. (2021).Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. The Lancet, 397(10277), 892-901.

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Published

2025-02-20

Issue

Vol. 54 No. 4 (2025): Year 2025, Volume 54, Issue 4

Section

Articles

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How to Cite

Development and Validation of RP-HPLC Method for Determination of Pirtobrutinib in Bulk and Pharmaceutical Dosage Form (P. Ravi Sankar, V. Ujwala , P. Srihari Prasad , J. Jhansi Rani , B. Swathi , N. Paparao , B. Divya , P. Srinivasa Babu , Trans.). (2025). Cuestiones De Fisioterapia, 54(4), 6626-6643. https://doi.org/10.48047/hmmnms82