Abstract

VALIDATION OF A NEW ANALYTICAL METHOD FOR SIMULTANEOUSLY ESTIMATING MONTELUKAST AND BILASTINE BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Arjun Singh*, Ankit Diwan, Kuldeep Ganju

Sagar Institute of Pharmacy and Technology, Bhopal, Madhya Pradesh, India

ABSTRACT

A new reversed phase high performance liquid chromatography (RP-HPLC) method was developed for simultaneously estimating the concentration of montelukast and bilastine in formulation and it was validated according to ICH guidelines. The chromatogram was found to be satisfactory on C-18 (4.6×150mm, 5μ Thermosil column) using mobile phase composed of isoproylalcohol: phosphate buffer (pH 4.5) (80:20) at a flow rate of 1.0 ml/min and the detection wavelength of 260 nm. The retention time of monelukast and bilastine was found to be 1.81 and 3.62 min respectively. The system suitability parameters proved that the proposed method is suitable for estimation of both the drugs under study. The number of theoretical plates for separation was found to be 13569 and 15576 with a tailing factor of 1.084 and 1.285 respectively for montelukast and bilastine. The linearity for the drugs was studied from 10 to 50 μg/ml concentrations. The precision of the method was good and the recovery of drugs was found to be within the prescribed limits of acceptance (50-150%) The LOD and LOQ were found to be 0.003 μg/mL and 0.012 μg/mL respectively for montelukast and 0.09 μg/ml and 0.3 μg/ml respectively for bilastine. The proposed RP HPLC method was found suitable for the estimation of montelukast and bilastine in dosage forms (tablet) and is simple, selective, reproducible and accurate with good precision and can be successfully applied to routine analytical purpose.

Keywords: Montelukast, Bilastine, ICH guidelines, Dosage form, HPLC.