Development and Validation of RP-HPLC Method for the Determination of Anticancer Drug Brigatinib
1 Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.
2 Research and Development Department, Incepta Pharmaceutical Company, Zirabo, Ashulia, Dhaka, Bangladesh.
Research Article
GSC Biological and Pharmaceutical Sciences, 2023, 23(03), 030–041.
Article DOI: 10.30574/gscbps.2023.23.3.0215
Publication history:
Received on 18 April 2023; revised on 30 May 2023; accepted on 01 June 2023
Abstract:
Now-a-days, one of the most devastating and life-threatening disorders is cancer. Various types of cancer based on the organ affected are namely lung cancer, breast cancer, stomach cancer, colon cancer etc. A number of anticancer drugs are obtainable among which tyrosine kinase inhibitor is the superior one. The available tyrosine kinase inhibitors are namely Crizotinib, Ibrutinib, Osimertinib, Brigatinib. Among them, brigatinib is the recent INN drug which belongs to second generation of tyrosine kinase inhibitor and indicated for non-small cell lung cancer. Literature review shows that there are no developed methods available for determination of brigatinib except UPLC method. In the present study, authors aimed to develop and validate RP-HPLC method for determination of brigatinib. Regarding RP-HPLC method, C18 column (ID: 5 micron*100 Å) was employed as stationary phase while combination of methanol and distilled water (75%:25%) was used as mobile phase. The retention time of brigatinib was found 5.6 min from the chromatogram. The regression equation was y = 53344x - 239.6 with coefficient of determination (R2) 0.999 and correlation coefficient (r) 0.9994; indicating excellent linearity of the calibration curve obtained by the newly developed method. Percent (%) RSD for robustness, ruggedness, precision was below 2. Limit of detection and limit of quantification were found to be 0.332 μg/mL and 1.00 μg/mL, respectively. The findings ensure the suitability of the developed method as an established one to assay brigatinib in any quality control laboratory.
Keywords:
Brigatinib; Method validation; RP-HPLC; Quality control; ICH guidelines; Limit of quantification (LOQ)
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Copyright © 2023 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
