Abstract

DEVELOPMENT AND VALIDATION OF A UV SPECTROSCOPIC METHOD FOR ANALYSIS OF BILASTINE IN BULK AND TABLET FORM

Harsha K. M.*, Suresha D. N. and Naveen Kumar G. S.

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Abstract

Bilastine in bulk and pharmaceutical dose form can be estimated using a straightforward, accurate, and precise zero-order derivative UV spectroscopic approach that has been developed and validated. The absorbance of Bilastine in ethanol reaches its maximum at 278 nm, and its concentration falls between 2 and 12 μg/ml according to Beer's Law. After conducting a linearity investigation, the regression coefficient (R2) was shown to be 0.999, indicating good linearity and precision across this concentration range. The limits of detection (LOD) and quantitation (LOQ) were determined to be 0.0646 μg/ml and 0.196 μg/ml, respectively, while the percentage recovery was determined to be 98.63% and 100.10%. Additionally, the method's relative standard deviation (%RSD) values were less than 2%, indicating exceptional precision. Following ICH criteria, all validation parameters—linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ—were evaluated. Bilastine in bulk and pharmaceutical dosage forms can be routinely estimated using the designed and tested approach.

Keywords: Bilastine, Zero order derivative spectroscopy , Validation , Pharmaceutical formulations.