UPLC-PDA Approach for Simultaneous Quantification of Elvitegravir, Tenofovir, Emtricitabine and Cobicistat in Tablets: An MS-ESI Study for Degradation Products.

Autor:	Nimmagadda RL; Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Gandhi nagar, Rushikonda, Visakhapatnam, Andhra Pradesh 530045, India., Gummadi S; Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Gandhi nagar, Rushikonda, Visakhapatnam, Andhra Pradesh 530045, India.
Jazyk:	angličtina
Zdroj:	Journal of chromatographic science [J Chromatogr Sci] 2024 Oct 01; Vol. 62 (8), pp. 719-731.
DOI:	10.1093/chromsci/bmad067
Abstrakt:	A simultaneous ultra-performance liquid chromatography photodiode array detection method was developed and validated for Elvitegravir, Tenofovir and Emtricitabine and Cobicistat drugs in tablet dosage forms. Effective liquid chromatographic quantification was achieved using a Luna C18 (100 × 2.6 mm, 1.6 μ) column with an acetonitrile: 0.1% v/v trifluoro acetic acid (80:20% v/v) mobile phase and a photo diode array detector at 260 nm for a shorter run time of 3 min. The respective retention times for Elvitegravir, Tenofovir, Emtricitabine and Cobicistat were 0.311, 0.792, 1.379 and 2.045 min. The range of linearity was 37.50-225.00, 2.50-15.00, 50.00-300.00 and 37.50-225.00 μg/mL for Elvitegravir, Tenofovir, Emtricitabine and Cobicistat, respectively. A mass spectrometer was employed for quantitative analysis using electron spray ionization multiple reaction monitoring in positive mode. The developed method was validated for different parameters to meet the acceptance criteria as per ICH Q2 (R1) guidelines. Using UPLC-ESI-MS, 12 degradants were identified and their mechanisms were studied. (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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