Spiked Human Plasma Samples: Stability Indicating Method Development and Validation of Pexidartinib by LCMS
Velagapudi Naga Venkata Kishore1★, Giri Prasad Gorumutchu1★, Khandapu Bala Murali Krishna2★★ Corresponding author
- 1Department of Chemistry, A.G and S.G. Siddhartha Degree College of Arts and Science, Vuyyuru, Andhra Pradesh, INDIA.
- 2Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Andhra Pradesh, INDIA.
CORRESPONDENCE
Velagapudi Naga Venkata Kishore
Dr. Giri Prasad GorumutchuDepartment of Chemistry, A.G and S.G. Siddhartha Degree College of Arts and Science, Vuyyuru-521165, Andhra Pradesh, INDIA.
Received: 23-06-2024; Revised: 15-09-2024; Accepted: 02-01-2025.
Volume 59, Issue 2S · pp. s748–s757 · PUBLISHED Apr-Jun 2025 · DOI: 10.5530/ijper.20256947
ABSTRACT
Aim: Pexidartinib (PDTB) was utilized in the development of a novel bioanalytical LCMS method in human plasma, with Talazoparib (TZPB) serving as the IS (Internal standard). Materials and Methods: The chromatographic separation was accomplished using an Xbridge C18 column (50 mM×4.6 mM, 5 μM) with an Acetonitrile-based simple isocratic mobile phase composition: Throughout the study, 0.6 mL/min of methanaol:0.1% orthophosphoric acid (35:35:30) was flow-regulated. Results and Discussion: In the positive ion mode, mass spectra of Pexidartinib (PDTB) and Talazoparib (TZPB) were discovered at m/z 418→153 and m/z 381→108, respectively. The study took 5 min to complete and had a strong linearity in the 0.5-500 ng/mL range with a correlation coefficient (r) of 0.999. The original ranges for the % RSD of the method and the intermediate precision of the PDTB were 0.29-1.13 and 0.13-1.01, respectively. LOD and LOQ were 0.5 μg mL-1 and 0.05 μg mL-1, respectively, and more than 90.0% of the samples were recovered. Conclusion: The bioanalytical method's validation was conducted in compliance with the ICH recommendations. The proposed LC-MS method has been effectively applied for routine analysis and bioanalysis, thanks to the produced promising results that are simple, precise, reliable, sensitive, and robust.
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Kishore, V. N. V., Gorumutchu, G. P., & Krishna, K. B. M. (2025). Spiked Human Plasma Samples: Stability Indicating Method Development and Validation of Pexidartinib by LCMS. Indian Journal of Pharmaceutical Education and Research, 59(2S), s748–s757. https://doi.org/10.5530/ijper.20256947