Stability indicating HPLC method development and validation of Fostemsavir in bulk and marketed formulations by implementing QbD approach
Journal Title: International Journal of Experimental Research and Review - Year 2023, Vol 30, Issue 1
Abstract
Background: Achieving a predictable degree of quality with intended and planned specifications is known as "quality by design." QbD (Quality-by-Design) is an alternative to conventional method development that places more attention on identifying and mitigating potential risks. Component of the Quality-by-Design methodology involves conducting a series of experiments to learn how various factors, including the dependant variables, affect the answers of interest. Here, we use a QbD (Quality-by-Design) loom to detail the creation and verification of a stability-indicating high-performance liquid chromatography (HPLC) method for Fostemsavir in both bulk and finished-goods forms.
Authors and Affiliations
Mahesh Deshpande, Sejal Barge, Khushabu Patil, Asmita Gaikwad, Lokesh Barde, Nitin Deshmukh
Keywords
Related Articles
- EP ID EP715454
- DOI https://doi.org/10.52756/ijerr.2023.v30.030
- Views 76
- Downloads 0
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