SIMULTANEOUS AND ESTIMATION OF MONTELUKAST AND BILASTINE BY USING RP-HPLC METHOD WITH STABILITY INDICATING
Keywords:
RP-HPLC, Bilastine ,Montelukast, ICH GuidelinesAbstract
An easy-to-use, precise method was developed for the simultaneous estimation of bilastine and montelukast in bulk and tablet dose form. Chromatogram was run through Inertsil C18 150 x 4.6 mm, 5μm. mobile phase comprising 0.01N disodium hydrogen phosphate and in the ratio of (70:30) was pumped through column at a flow rate of 1.0ml/min. 30°C was kept as the temperature. The chosen optimized wavelength was 230.0 nm. Retention time of Bilastine & Montelukast were 2.523 min & 3.140 min respectively. Bilastine &Montelukast %RSD were determined to be 1.2 and 0.6% respectively. %Recovery of Bilastine & Montelukast were 99.55% & 99.51 %respectively. Bilastine & Montelukast ’s regression equation yielded LOD and LOQ values of 0.16,0.48ppm and 0.12,0.36ppm. Bilastine regression equation is y = 62266x + 12857 and Montelukast regression equation is 72927x + 8987. Stability experiments of Bilastine & Montelukast under distinctive environments of stress were also performed. As a result of shorter retentions durations and shorter run times, the method was created to be straightforward and cost-effective, and it may be used for routine Quality Control Tests in Industries.
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