UTILITY OF QUALITY BY DESIGN APPROACH IN RP-HPLC METHOD DEVELOPMENT FOR QUANTIFICATION OF LAMIVUDINE AND EFFAVIRENZ IN COMBINATION FORMULATION

Authors : Bhagavan Rajesh Babu KOPPİSETTY, Prof Y Rajendra PRASAD, Krishna Manjari Pawar AMGOTH, Srinivasa Rao YARRAGUNTLA, Vasudha DADI, Hemant Kumar TATAPUDI

Pages : 625-636

Doi:10.33483/jfpau.1181816

View : 19 | Download : 11

Publication Date : 2023-05-20

Article Type : Research Paper

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