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IJNRD
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
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Impact Factor : 8.76

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Paper Title: Analytical Method Development And Validation of Brexpiprazole Along With Stability Indicating Method By Quality By Design Approach
Authors Name: Darshit. S. Trivedi , Kavita. R. Desai
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IJNRD_181419
Published Paper Id: IJNRD2205128
Published In: Volume 7 Issue 5, May-2022
DOI: http://doi.one/10.1729/Journal.30453
Abstract: A chromatographic method for determination of assay of Brexpiprazole was developed using Quality by design approach. QBD is a standardized approach for the process development. The method development by QBD begins with the predefined objectives. In this modern era of pharmaceuticals, the perception of QBD is extended to analytical method development. In present work a simple method was developed and two critical attributes were focused for developing the robust and rugged method. Total of 13 experiments were suggested by the Design Expert software using the central composite method, in which, the flow rate and the proportion of solvent were focused. The central composite method is widely used for the method development because of its accuracy in a smaller number of experiments. The implication of self-sufficient factors was resolved using Fisher’s statistical test for Analysis of the Variance (ANOVA) model that was predicted. Primesil C-18 column (250mm*4.6mm*5µ) was found to be suitable as it produced the symmetrical peaks. The wavelength on which the detection was carried is 215nm with Phosphate Buffer pH 3.5 as mobile phase A and Acetonitrile 100% as mobile phase B. The validation parameters such as specificity, accuracy, linearity, repeatability, robustness and solution stability were carried out and this method can be used for judgement of quality of API. The forced degradation study was also carried out and no interference of any unknown peak found with main peak.
Keywords: Chromatography, HPLC, Analytical Method development, QBD approach, Brexpiprazole, Antipsychotic Drug, Design Expert
Cite Article: "Analytical Method Development And Validation of Brexpiprazole Along With Stability Indicating Method By Quality By Design Approach", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.7, Issue 5, page no.1047-1053, May-2022, Available :http://www.ijnrd.org/papers/IJNRD2205128.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
Publication Details: Published Paper ID:IJNRD2205128
Registration ID: 181419
Published In: Volume 7 Issue 5, May-2022
DOI (Digital Object Identifier): http://doi.one/10.1729/Journal.30453
Page No: 1047-1053
Country: Ahmedabad, Gujarat, India
Research Area: Engineering
Publisher : IJ Publication
Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2205128
Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2205128
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ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
Journal Starting Year (ESTD) : 2016

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