Asian Journal of Research in Chemistry

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Estimation and Validation of Bilastine in Pharmaceutical Dosage Form and in Bulk Drug by Spectrophotometric Method


Affiliations
1 Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India ., India
2 Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India., India
     

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A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Bilastine in pure drug and tablet dosage form. The absorbance was measured at 226.2nm using Methanol as solvent system. It obeyed Beer’s law at the concentration range of 2-12µg/ml with coefficient of correlation (r2) of 0.9993. Limit of detection (LOD) was found to be 1.224µg/ml and Limit of quantitation (LOQ) was found to be 4.088µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.

Keywords

Bilastine, Antihistamine, Spectrophotometry, Methanol, method validation.
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  • Estimation and Validation of Bilastine in Pharmaceutical Dosage Form and in Bulk Drug by Spectrophotometric Method

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Authors

Afnaz Jahan
Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India ., India
Mohamed Khaleel
Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India., India
Husnain Fathima
Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India ., India

Abstract


A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Bilastine in pure drug and tablet dosage form. The absorbance was measured at 226.2nm using Methanol as solvent system. It obeyed Beer’s law at the concentration range of 2-12µg/ml with coefficient of correlation (r2) of 0.9993. Limit of detection (LOD) was found to be 1.224µg/ml and Limit of quantitation (LOQ) was found to be 4.088µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.

Keywords


Bilastine, Antihistamine, Spectrophotometry, Methanol, method validation.

References