DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF APREMILAST IN HUMAN PLASMA (K3EDTA) BY USING LC-MS/MS

Shravan Goski , Dr.P.Venkatesh

Apremilast, LC-MS/MS, Human Plasma(K3EDTA).

A sensitive and reliable liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the quantification of Apremilast, a novel therapeutic agent, in human plasma samples. The method utilizes multiple reaction monitoring (MRM) mode with specific transitions for Apremilast and its stable isotope-labeled internal standard (Apremilast-D5). Chromatographic separation was achieved on a Unisol C18, 4.6x100mm, 5µm column using a mobile phase consisting of acetonitrile and water with 0.2%formic acid(90:10v/v). Liquid-liquid extraction (LLE) was optimized for efficient extraction of Apremilast from plasma matrices, ensuring minimal matrix interference and high recovery. Method validation was performed according to International Council for Harmonisation (ICH) guidelines, demonstrating satisfactory results for specificity, linearity, accuracy, precision, sensitivity, dilution integrity, and stability. The method exhibited a linear calibration range of 1.0–1000.0 ng/mL, with excellent accuracy (% accuracy ranged from 95.82% to 105.85%) and precision (%CV ≤ 15%) across quality control samples. Furthermore, stability testing confirmed the stability of Apremilast in various conditions, including refrigerated storage, autosampler conditions, and freeze-thaw cycles. The developed LC-MS/MS method offers a robust and sensitive approach for the quantitative determination of Apremilast in plasma samples, suitable for pharmacokinetic studies and therapeutic drug monitoring.

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"DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF APREMILAST IN HUMAN PLASMA (K3EDTA) BY USING LC-MS/MS ", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.9, Issue 5, page no.1173 - 1194, May-2024, Available :https://ijsdr.org/papers/2405155.pdf

Volume 9 Issue 5, May-2024

Pages : 1173 - 1194

Paper Reg. ID: IJSDR_211265

Published Paper Id: 2405155

Downloads: 000347231

Research Area: Pharmacy

Country: Hyderabad, Telangana, India

Published Paper PDF: https://ijsdr.org/papers/2405155

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=2405155

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

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