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Method Development And Validation For The Quantification Of Pexidartinib In Biological Samples By Lc-Ms/Ms
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| Author:
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SHANKAR CHERUKU, D.V.R.N.BHIKSHAPATHI
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| Abstract:
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Pexidartinib is an anticancer drug targeting tyrosine kinase inhibition by blocking colony stimulating factor (CSF-1) or its receptor (CSF1R) path. In this study, a highly specific and sensitive LC-MS/MS-based bioanalytical method was developed and validated for the quantification of pexidartinib anti-cancer drug. The protein precipitation method was subjected for the analyte extraction from the plasma samples and elution was processed on BEH (50 mm× 2.1 mm , 1.7 µ) C18 reverse phase column. Separation was executed with isocratic solvent system comprising of acetonitrile, methanol and 0.1% formic acid in the composition of 15:70:15%V/V with flow rate of 0.6 ml/min. The drug and brigatinib internal standard were estimated in multiple reaction monitoring technique with +ve electrospray ionization with specific pair of mass by charge ratio. All standard validation parameters were assessed as per current bioanalytical method validation guidelines. The area response for the four analytes was found to be linear over the concentration range of 2.5 to 5000 ng/ml in plasma samples. The intra- and inter-batch precision were less than 3.27 and 2.86 respectively and accuracy values were present in between 96.73 to 103.64.
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| Keyword:
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Pexidartinib, anticancer, Bioanalytical method, Accuracy, sensitivity.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.831
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| Download:
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