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DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC ESTIMATION OF EBASTINE IN BULK AND TABLET DOSAGE FORM USING AREA UNDER CURVE METHOD

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Author(s): Dahivadkar Manish Sudhakar | Jain Hemant Kumar | Gujar Kishore Namdeorao

Journal: International Research Journal of Pharmacy
ISSN 2230-8407

Volume: 4;
Issue: 6;
Start page: 201;
Date: 2013;
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Keywords: Ebastine | UV Spectrophotometry | area under curve (AUC) | Estimation | Validation.

ABSTRACT
The aim of this work is to develop a simple, accurate, reproducible and cost effective spectrophotometric method for determination of Ebastine in bulk and pharmaceutical dosage form. This method is basedon area under curve (AUC) in wavelength range of 247-257nm and method has followed linearity in the concentration range of 5-30μg/ml. Methanol was used as a solvent. The developed analytical method was validated as per International Conference on Harmonization (ICH) guidelines. The value of correlation coefficient (R2) was 0.999. Limit of Detection and Limit of Quantitation were calculated as 0.78µg/ml and 2.37µg/ml, respectively. Results of the recovery studies showed good accuracy of the method. Validation results suggest that the developed method can be used for routine quality control studies for assay of Ebastine in bulk and tablet dosage form.
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