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DETERMINATION OF MIRABEGRON FOR QUALITY CONTROL TESTS IN PHARMACEUTICAL DOSAGE FORM

. Nalanda B. Revu, Sailesh K. Vegam, O. Rakesh, Anusha L & Santoshi K. Jajula.


Abstract

An accurate, precise, and highly selective spectrophotometric method was determined the estimation of mirabegron for quality control tests in pharmaceutical dosage forms. The method involves the measurement of absorbance at a wavelength of 251 nm. Validation was performed according to ICH guidelines. Beers law obeyed in the concentration range of 2-14 µg/mL, were found to be linear. It showed good reproducibility and recovery with a relative standard deviation of less than 2 %. The limit of detection and quantification was found to be 0.15 and 0.48 µg/mL. Thus, the proposed method was found to be specific in the presence of other excipients, precise and accurate quality control tools for routine analysis of mirabegron in pharmaceutical dosage form.

Keywords: Mirabegron, Spectrophotometry, Quality control, ICH, Validation, Beers law

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