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

KOPPİSETTY, Bhagavan Rajesh Babu; YEJELLA, Rajendra Prasad; AMGOTH, Krishna Manjari Pawar; YARRAGUNTLA, Srinivasa Rao; DADI, Vasudha; TATAPUDI, Hemant Kumar

Objective: For the measurement of lamivudine(LAM) and effavirenz (EVZ) in combination formulation, an uncomplicated and reliable liquid chromatographic approach has been proposed. Material and Method: The design of experiments (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 (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 (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.

HIGH performance liquid chromatography; LAMIVUDINE; MATHEMATICAL models; DRUGS; WAVELENGTHS

Journal of Faculty of Pharmacy of Ankara University / Ankara Üniversitesi Eczacilik Fakültesi Dergisi, 2023, Vol 47, Issue 2, p625

1015-3918

Academic Journal

10.33483/jfpau.1181816