Paper Title
HPLC Method Development and Validation for Estimation of Apremilast in Bulk and Tablet Dosage Form
Article Identifiers
Authors
R.Radha , D.Vineetha , K.V.Nanda Kumar , M.Kishore Babu , S.Siva Sankara ,V .Anitha Kumari
Keywords
Reverse Phase High performance liquid chromatography (RP-HPLC), Apremilast, Validation
Abstract
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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How To Cite (APA)
R.Radha, D.Vineetha, K.V.Nanda Kumar , M.Kishore Babu, & S.Siva Sankara ,V .Anitha Kumari (January-2024). HPLC Method Development and Validation for Estimation of Apremilast in Bulk and Tablet Dosage Form. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(1), a696-a703. https://ijnrd.org/papers/IJNRD2401080.pdf
Issue
Volume 9 Issue 1, January-2024
Pages : a696-a703
Other Publication Details
Paper Reg. ID: IJNRD_212080
Published Paper Id: IJNRD2401080
Downloads: 000121988
Research Area: Engineering
Country: -, -, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2401080.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2401080
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Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)
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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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