HPLC Method Development and Validation for Estimation of Apremilast in Bulk and Tablet Dosage Form

HPLC Method Development and Validation for Estimation of Apremilast in Bulk and Tablet Dosage Form

Registration ID: IJNRD_212080

Published ID: IJNRD2401080

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R.Radha , D.Vineetha , K.V.Nanda Kumar , M.Kishore Babu , S.Siva Sankara ,V .Anitha Kumari

Reverse Phase High performance liquid chromatography (RP-HPLC), Apremilast, Validation

This study presents a new RP-HPLC method for the quantification of apremilast in both bulk and pharmaceutical tablet forms. The method uses a SunQ C18 column with a mobile phase of acetonitrile: sodium acetate buffer (pH 5) in the ratio of 80:20 and a flow rate of 1.0 ml/min Detection at 230 nm, with a sharp peak at 3.692 minutes for apremilast work. The method exhibits good linearity (r2 = 0.995) over a concentration range of 5-30 µg/mL. Strict ratings follow ICH Q2 R1 guidelines, emphasizing accuracy, precision and robustness. The detection and quantitation limits were set at 0.519 μg/mL and 1.572 μg/mL, respectively. This simple and sensitive method provides a reliable tool for the production of apremilast, which is commonly used in clinical trials.

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"HPLC Method Development and Validation for Estimation of Apremilast in Bulk and Tablet Dosage Form", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.9, Issue 1, page no.a696-a703, January-2024, Available :https://ijnrd.org/papers/IJNRD2401080.pdf

Volume 9 Issue 1, January-2024

Pages : a696-a703

Paper Reg. ID: IJNRD_212080

Published Paper Id: IJNRD2401080

Downloads: 000121141

Research Area: Engineering

Country: -, -, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2401080.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2401080

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

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This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition

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