Utility of Quality by Design approach in RP-HPLC method development for quantification of lamivudine and effavirenz in combination formulation

Objective: For the measurement of lamivudine(LAM) and effavirenz (EVZ) in combination formulation, a uncomplicated reliable liquid chromatographic approach has been proposed.
 Material Method: Multivariate optimization RP-HPLC method, experimental conditions were accomplished using design experiments (DoE). The crucial method parameters determined by risk assessment. mathematical models created three independent variables: percentage acetonitrile, methanol, buffer pH. impacts these elements thoroughly investigated central composite (CCD), which was utilized to analyze response surface methodology. 
 Result Discussion: LAM EVZ retention time resolution both concurrently optimized desirability function. Acetonitrile, phosphate (pH 7.0) proportions 40:20:40 v/v each used anticipated data from contour diagram, with detection occurring at wavelength 215 nm. Baseline separation pharmaceuticals high run under 6 minutes ideal conditions. validated test followed ICH recommendations. As consequence, findings demonstrated that Quality Design methodology could be successfully optimize technique for concurrent quantification EVZ.