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)
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.
"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
Downloads:
000118748
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
Facebook Twitter Instagram LinkedIn