Abstract

METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF BRISOPROLOL FUMERATE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UV SPECTROMETRIC METHOD USING WATER AS SOLVENT

Swati S. Rawat* and Ganesh Dewan

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Abstract

A rapid, simple, selective and precise UV- Visible Spectrophotometric method has been developed for the determination of Brisoprolol Fumerate in bulk forms and tablet dosage formulations. The spectrophotometric detection was as per carried out at an absorption maximum of 223 nm using water as solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector response for was linear over the selected concentration range 10-50 ug/ml with a correlation coefficient(R2) of 0.9981. The accuracy was carried out as per recovery study and found between 99.65%% to 100.45%. The results demonstrated that the excipients in the tablets did not interfere with the method and can be conveniently employed for routine quality control analysis of metformin in bulk and formulation.

Keywords: UV Spectroscopy; Method Development; Validation; Brisoprolol Fumerate and ICH Guideline.