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International Journal of
Chemical Science
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VOL. 5, ISSUE 1 (2021)
Implementation of quality by design approach to method development and validation of daclatasvir on UV spectroscopy
Authors
Monika Jadhao, Madhuri D Game
Abstract
The application of QbD in analytical method development focused on the building quality into the method Quality is the heart of pharmaceutical industry. Daclatasvir an antiviral agent was estimated by uv spectrophotometric method followed by methanol used as solvent. The spectrum shows the maximum peak amplitude at 317 nm. graph shows linear in the range of 05- 30 µg/ml. The graphical optimization done with the help of Design Expert software version 10. Three factor with three level randomized response surface designs on a Box-Behnken design were used with 17 trial impact on the one key response variables. Optimized responses were selected validation. Validation was done according to International Conference on Harmonization. Good co-relation between responses and concentration was found as value of regression coefficient R2 is 0.999. The accuracy of the method was ranged in between 98.75-99.79 was in acceptable range. The percentage RSD values for method precision for all the methods were within the limit of ≤ 2. From the data it was concluded that the methods developed have scope to be applied for quantitative estimation of Daclatasvir.
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Pages:11-17
How to cite this article:
Monika Jadhao, Madhuri D Game "Implementation of quality by design approach to method development and validation of daclatasvir on UV spectroscopy". International Journal of Chemical Science, Vol 5, Issue 1, 2021, Pages 11-17
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