Research Article
RP-HPLC Method Development and Validation for Emtricitabine and Tenofovir Alafenamide fumarate in bulk drug and its degraded products using
Design of Experiments
Author(s): Arun M. Kashid*, Dhanshree S. Mhatre, Shraddha V. Tathe, Moreshwar P. Mahajan and Pranali P. Polshettiwar
RP-HPLC method development was successfully done using an innovative methodology based on the design of experiments (DoE), independent component analysis (ICA), and design space (DS). The Quantification of an HIV drug combination of Emtricitabine and Tenofovir alafenamide fumarate was done using DoE. Initially, independent variables that affect the dependent variables were analyzed and the Box Behnken design was used to study the interaction between the independent variables and dependent variables. The variables selected were % of the aqueous phase, flow rate, and wavelength. These variables were then optimized using the response surface methodology. The optimization was done using 2D contour plots and 3D response surface plots which provided a defined design space that had optimized chromatographic conditions that consist of mobile phase methanol: water (40:60 v/v) with pH adjusted .. Read More»
DOI:
10.4172/0975-413X.14.7.29-48
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