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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Analytical Method Development And Validation For Estimation Of Bilastine In Pharmaceutical Formulationby Reverse Phase High Performance Liquid Chromatography

Author: SRINIVAS AMPATI
Abstract: In this currentinvestigationeffort, an effort was made to build up anuncomplicated, speedy, truthfulas well as robust HPLC technique for the assessment of Bilastine in its tablet dosage form. Reverse phase high performance liquid chromatographic analysis was carried out on isocratic system. The column used for the investigation was Phenomenex C18 (250 mm× 4.6mm, 5µm) with ambient temperature. The optimized mobile phase was Methanol: Acetonitrile in the ratio of (20:80 %V/V). The detection was carried out at a wavelength of 245 nm using a flow rate of 1ml/min. The urbanizedtechnique was validated for validationconstraints like linearity, specificity, accuracy, precision as per ICH strategy. The %RSD for all constraints was well within the limits, which indicates the validity of the techniquein addition tothe assay results obtained are in reasonableconformity with the label claim of the marketed formulation. Thus, the conventionalscheme can be anticipated for repetitive investigation of this drug in laboratories and for superiority purposes.
Keyword: Bilastine, Acetonitrile, HPLC, Linearity.
DOI: https://doi.org/10.31838/ijpr/2020.12.04.680
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