Abstract

Sivasanker Reddy Lingareddygari^1*
, Nageswara Rao Ravikrindhi¹, Ishaq Mohammed Beludari², Dastagiri Reddy Yennam³, Madana Gopal Nookala¹ and Surendra Kammari¹

DOI : http://dx.doi.org/10.13005/ojc/390325

Background: The Bilastine is a H1 receptor antagonist, used in the treatment of allergic urticaria, seasonal rhinitis etc. Few journals have reported the analytical related work on bilastine drug. Objective: The objective of the work is to develop a simple, precise, rapid and reproducible method, using design of experiments (DOE) and check the optimized conditions when run on Ultra Flow Liquid Chromatography(UFLC) would give the best method or not. Results: The DOE software was used to select optimized conditions with minimal runs. The central composite design was the best fit, with two variables that include flow rate and column temperature. A total of 13 runs gave optimum conditions of 1.2 ml/min flow rate, column temperature of 40°C and mobile phase-methanol: buffer (pH 6.0) in the ratio of 70:30 in the binary mode using the Shimadzu C18 column on an HPLC instrument. The retention time of bilastine was found to be 5.126min, the number of theoretical plates and asymmetric factor being within the limit. The proposed method was validated as per the ICH Q2R1 guidelines. The linearity was found to be in the range of 1.25µg/ml-10µg/ml. The correlation coefficient was found to be within the limits i.e., R2= 0.999. The accuracy of the current method was being performed using the % recovery at three stages 50%, 100%, and 150% and was found to be 99.5126%, 100.2765% and 99.6714% respectively. The LOD and LOQ of the bilastine was found to be 0.2094µg/ml and 0. 6346µg/ml.
Conclusion: The DOE software reduced the number of trials, saving both time and solvents consumption. This method can be conveniently used with confidence for regular assay, which is simple, precise, rapid and reproducible one for the estimation of bilastine in pure and pharmaceutical tablet dosage form using UFLC.

Bilastine; Design of Experiment(DOE); ICH Q2R1 guidelines; Mdethod development; RP-UFLC

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