Analytical quality by design approach to RP- HPLC method development, optimization and validation for simultaneous estimation of Dolutegravir and Rilpivirine
This study uses a design of experiments framework to optimize HPLC for analyzing Dolutegravir and Rilpivirine, emphasizing method validation and optimization.
Key Points
The developed HPLC method shows high accuracy, with results between 98–102%, ensuring reliable simultaneous estimation of both drugs.
Optimization through Central Composite Design established key chromatographic parameters, improving method performance and robustness.
Forced degradation studies indicate the method's stability-indicating capability, with drug degradation levels ranging from 3.25% to 23.9%.
Over 90% of response variability is accounted for by quadratic and interaction models, highlighting the significance of pH and flow rate in the method.