STABILITY INDICATING ISOCRATIC HPLC APPROACH TO QUANTIFY MONTELUKAST AND BILASTINE MIX IN BULK AND TABLET FORMULATION

Abstract

This paper describes an novel, rapid, simple, meticulous and unerring “stability indicating HPLC method” for the assessment of montelukast (MTT) and bilastine (BLE) mix in existence of their degradation products in tablet formulation. Zorbax column XDB-C18 was utilized to separate and analyse MTT and BLE mix. The isocratic mode elution of BLE and MTT mix was made with 0.1M disodium hydrogen phosphate buffer of pH 5.8 (55 % volume ratio) and methanol (45% volume ratio) at 1.0 mL min-1 flow stream. Strong linearity was recorded within the 2.5 - 20 µg mL-1 and 5 - 40 µg mL-1 concentration ranges, with coefficient determination values of 0.9994 and 0.9997, respectively, for MTT and BLE. The recovery percentiles of MTT and BLE were 99.593 % and 99.349 %, respectively. The precision displayed values less than 0.520 % for MTT and less than 0.745 % for BLE. The robustness too was shown in the chromatographic settings by minor variations. The specificity besides stability representing feature was evidenced since the degradation products arisen in stress situations did not interlope in the determination of MTT and BLE mix. Thus, this procedure can be applied for quality regulation analysis of BLE and MTT mix in formulations of tablets.