A sensitive bioanalytical method development and validation of afatinib in human plasma by LC-ESI-MS/MS

Asha Deepti; Alapati Sahithi

doi:10.53730/ijhs.v6nS5.9522

A sensitive bioanalytical method development and validation of afatinib in human plasma by LC-ESI-MS/MS

https://doi.org/10.53730/ijhs.v6nS5.9522

Authors

Asha Deepti Assistant Professor, Department of Pharmaceutical Analysis GITAM Institute of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam, Andhra Pradesh, India-530045
Alapati Sahithi
salapati1@gitam.in
Research scholar, GITAM Institute of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam, Andhra Pradesh, India-530045 & Assistant professor, Department of Pharmaceutical Analysis, School of Pharmacy, Nalla Narasimha Reddy Education Society’s Group of Institutions, Hyderabad, Telangana, INDIA-500088

Keywords:

Afatinib, Cabozantinib, Internal standard, Flow rate

Abstract

A simple, sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the quantification of Afatinib in human plasma using Cabozantinib as an internal standard (IS). Chromatographic separation was performed on Water X Bridge c18 2.1x100 column with an isocratic mobile phase composed of acetonitrile and 0.2% Ammonia in water in the ratio of (70:30 v/v), at a flow rate of 0.250mL/min. Afatinib and Cabozantinib were detected with parent ions at m/z 486.36 to 370.90 and the daughter mass was found to be 381.45 to 304.93 in multiple reaction monitoring (MRM) positive mode respectively. The protein precipitation method was used to extract the drug and IS. The method was validated over a linear concentration range of 2.0-1000.0 ng/mL with a correlation coefficient (r2) ≥ 0. 9994. This method demonstrated Intra and inter-day Precision within 0.3 to 2.5 and 0.4 to 3.9 % and Accuracy from 96.55 to 105.45 and 95.26 to 110.6%. Afatinib was found to be stable throughout Long-term stability studies, benchtop, and postoperative stability studies.

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Published

23-06-2022

How to Cite

Deepti, A., & Sahithi, A. (2022). A sensitive bioanalytical method development and validation of afatinib in human plasma by LC-ESI-MS/MS. International Journal of Health Sciences, 6(S5), 1736–1384. https://doi.org/10.53730/ijhs.v6nS5.9522

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Issue

Vol. 6 No. S5 (2022)

Section

Peer Review Articles

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