Author(s): N S Yamani, Mukthinuthalapati Mathrusri Annapurna, Prava Venkata Raj Kumar

Email(s): mmukthin@gitam.edu

DOI: 10.52711/0974-360X.2023.00718   

Address: N S Yamani, Mukthinuthalapati Mathrusri Annapurna*, Prava Venkata Raj Kumar
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Visakhapatnam.
*Corresponding Author

Published In:   Volume - 16,      Issue - 9,     Year - 2023


ABSTRACT:
Dacomitinib is an anti-cancer drug. A new stability indicating isocratic RP-HPLC and LC-APCI-MS methods have been developed and validated for the quantification of Dacomitinib as per ICH guidelines. Thermo scientific-TSQ Quantis with Vanquish HPLC coupled with MS was employed for the present study. Simpack C18 column was used for chromatographic resolution and a triple quadrupole mass spectrometer with atmospheric pressure chemical ionization (APCI) source, running in the positive mode (as well as negative mode) was used for detection. A wide linearity concentration range 2.0-200 µg/ml was shown by the proposed method. The m/z transitions were: 404.20 ? 489.24. The proposed methods are simple, precise, accurate and used to quantify the marketed formulations of Dacomitinib.


Cite this article:
N S Yamani, Mukthinuthalapati Mathrusri Annapurna, Prava Venkata Raj Kumar. A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Dacomitinib in pharmaceutical dosage forms. Research Journal of Pharmacy and Technology 2023; 16(9):4391-8. doi: 10.52711/0974-360X.2023.00718

Cite(Electronic):
N S Yamani, Mukthinuthalapati Mathrusri Annapurna, Prava Venkata Raj Kumar. A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Dacomitinib in pharmaceutical dosage forms. Research Journal of Pharmacy and Technology 2023; 16(9):4391-8. doi: 10.52711/0974-360X.2023.00718   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2023-16-9-62


REFERENCES:
1.    Liao B-C, Lin C-C, Yang JC-H. Second and third-generation epidermal growth factor receptor tyrosine kinase inhibitors in advanced non-small cell lung cancer. Current Opinion in Oncology. 2015; 27(2): 94-101.
2.    U.S. Food and Drug Administration (FDA). Vizimpro® (dacomitinib) tablets. In: Center for Drug Evaluation and Research, editor. MD, USA 27th September 2018.
3.    Abdelhameed AS, Kadi AA, Attwa MW, AlRabiah H. Validated LC-MS/MS assay for quantification of the newly approved tyrosine kinase inhibitor, Dacomitinib, and application to investigating its metabolic stability. PLoS ONE. 2019; 14 (4): e0214598.
4.    Md. Lutful Kabir, Frederick Backler, Andrew H. A. Clayton and Feng Wang. Quantitative bioanalytical assay for the human epidermal growth factor receptor (HER) inhibitor dacomitinib in rat plasma by UPLC-MS/MS.  Journal of Pharmaceutical and Biomedical Analysis 2019; 166: 66-70.
5.    Qiu X, Lin Q, Ning Z, Qian X, Li P, Ye L, et al. Quantitative bioanalytical assay for the human epidermal growth factor receptor (HER) inhibitor dacomitinib in rat plasma by UPLC-MS/MS. Journal of Pharmaceutical and Biomedical Analysis. 2019; 166: 66-70.
6.    Kirti Kumari, Pankaj Thakur, Sayali Warde, Vijay M and Raman Mohan Singh. HPLC method development and validation for quantitative estimation of Dacomitinib in pharmaceuticals dosage form. Human Journals Research Article October 2021; 22(3): 606-620.
7.    ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).
8.    ICH Stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization (2003).

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DOI: 10.5958/0974-360X 

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