Optimization of HPLC Method by Using Central Composite Design for Simultaneous Estimation of Montelukast and Ebastine Dosage Form

Abstract

In this work, a novel method for the simultaneous estimate of Montelukast (MONT) and Ebastine (EBAS) in bulk drugs was developed using Central Composite Design (CCD).A novel reverse-phase high-performance liquid chromatography (RP-HPLC) approach for the simultaneous measurement of Montelukast and Ebastine in bulk and formulation is what this work aims to create and test.A novel reverse-phase high-performance liquid chromatography (RP-HPLC) approach for the simultaneous measurement of Montelukast and Ebastine in bulk and formulation is what this work aims to create and test.With isocratic elution at a flow rate of 0.8 ml min-1 and a diode array detector operating at 241 nm, the separation was accomplished using methanol and 0.02M ammonium acetate buffer (pH 5.5 adjusted with diluted acetic acid) in the ratio of 80:20 v/v. Methanol composition (percent) (A), pH (B), and flow rate (C) were three independent variables that were examined.This method showed good linearity over a range of 2.5–25 μg/ml for both drugs. MONT limit of detection (LOD) and limit of quantitation (LOQ) were 0.298 and 0.905μg/ml while LOD and LOQ for EBAS were 0.594 and 1.80For both drugs, this technique demonstrated high linearity throughout a range of 2.5–25 μg/ml. Limits of detection (LOD) and quantitation (LOQ) for MONT were 0.298 and 0.905 μg/ml and 0.594 and 1.80 μg/ml for EBAS, respectively.The statistical data analysis determined that the Methanol composition and pH were the two independent variables that were most significant, with P 0.001. The suggested technique worked well and was optimised for the CCD model-based simultaneous estimate of both drugs.