A New HPLC Stability Indicating Method and Validation for Simultaneous Quantitation of Bilastine and Montelukast Sodium in API and Marketed Formulation by QbD Approach

Abstract

A new HPLC stability indicating method was developed and optimized by using a statistical tool, design expert 13.0.1.0 (Stat-Ease) for simultaneous quantitation of bilastine and montelucast sodium in marketed tablet dosage form. Randomized response surface methodology with two factor central composite design was utilized for mobile phase optimization and the effect of the independent variables, flow rate and volume of organic phase on critical quality attributes, resolution and retention time was studied. The analytes were resolved on a inertsil C18 (150 × 4.6 mm) column with 5 μm particle size. Within the design space the optimum chromatographic condition chosen was 0.1% orthophosphoric acid with acetonitrile at 60:40 (%v/v) having a flow rate of 1 min/mL for 10 min. The retention time (Rt) for bilastine and montelucast sodium was 2.445 and 3.787 min, respectively. The method was completely validated as per the current ICH guidelines. Forced degradation was carried out in acidic, basic, photolytic, neutral, oxidation, thermal conditions to prove the stability indicating property of HPLC method. The method’s applicability was studied by determining bilastine and montelucast sodium in the marketed tablet dosage form. This validated RP-HPLC stability indicating method can be suggested for routine quality control analysis in industries and research laboratories for the fixed dose marketed tablet formulation.