INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
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.
Keywords:
Reverse Phase High performance liquid chromatography (RP-HPLC), Apremilast, Validation
Cite Article:
"HPLC Method Development and Validation for Estimation of Apremilast in Bulk and Tablet Dosage Form", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.9, Issue 1, page no.a696-a703, January-2024, Available :http://www.ijnrd.org/papers/IJNRD2401080.pdf
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ISSN:
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
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