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Validation Of A Specific Lc-Ms/Ms Method For The Quantification Of Anti-Cancer Alectinib In Biological Matrices
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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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Alectinib is a generation-II oral medicament that selectively constrains the action of anaplastic lymphoma kinase tyrosine kinase. It is specifically utilized to treat non-small cell lung cancer expressing the echinoderm microtubule-associated protein-like 4 fusion protein that causes proliferation of NSCLC cells. In this study, a highly specific and sensitive LC-MS/MS-based bioanalytical method was developed and validated for the quantification of alectinib anti-cancer drug. The protein precipitation method was subjected for the analyte extraction from the plasma samples and elution was processed on Phenomenex C18 50mm × 4.6 mm, 2.4 µ reverse phase column. Separation was executed with isocratic solvent system comprising of 0.1% formic acid and methanol in the ratio of 15:85 %V/V with flow rate of 0.7 ml/min. The drug and efavirenz 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 37.5 to 1500 ng/ml in plasma samples. The intra- and inter-batch precision were less than 3.61 and 3.31 respectively and accuracy values were present in between 96.84 to 103.94. The mean recovery findings were present in between 96.06 to 102.68%.
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| Keyword:
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Alectinib, Tyrosine kinase, Bioanalytical method, Validation, Linearity.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.830
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| Download:
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