Simultaneous Optimization of the Resolution and Analysis time in RP-HPLC of Fexofenadine and Montelukast using Derringer’s Desirability Function

Abstract

For the simultaneous study of fexofenadine and montelukast using statistical experimental design, a new simple, sensitive, rapid and precise isocratic RP-HPLC was developed and validated. For multivariate optimization of the experimental conditions of the RP-HPLC process, Experiment Architecture (DoE) was applied. Mathematical models were constructed using three independent factors: mobile phase structure, phosphate buffer intensity and flow rate. In order to research the response surface technique and to study in detail the results of these independent variables, central composite design (CCD) was used. The desirability feature was used to maximize the retention time and resolution of the analytes simultaneously.The optimized and projected contour diagram data consisted of a 75:25 mixture of acetonitrile and phosphate buffer (pH 6.5, pressure 49 mM) at a flow rate of 1.4 ml/min, respectively. Baseline isolation of both drugs with a reasonable resolution and run time of less than 9.0 min was accomplished using these optimal conditions. According to ICH instructions, the optimized assay conditions were validated. The findings thus explicitly showed that the Consistency by methodology could be successfully extended in order to perform analyses the RP-HPLC process for simultaneous fexofenadine and montelukast estimation.