Abstract

DEVELOPMENT AND VALIDATION OF DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF MIRABEGRON IN BULK AND TABLET DOSAGE FORM

R. Nageswara Rao, Dr. D. Madhuri, Dr. L Siva Sanker Reddy, K. Rani*, P. Tejaswini and Dr. Kumara Swamy. Gandla

Abstract

The present communication deals with development of simple, sensitive, rapid and economical method for estimation of mirabegron in bulk and tablet dosage form. The method of analysis is derivative spectroscopy to eliminate spectral interference by measuring absorbances at 246 nm and 213 nm for Zero order and 1st derivative spectroscopy respectively. It is linear in concentration range of 2-25 μg/ml respectively. The limit of detection (LOD) and limit of quantitation (LOQ) of drug was 0.80 & 0.47 and 2.43 & 1.42 μg respectively. The results of analysis were validated by ICH Q2B (R1). The results of recovery studies and precision were found to be within limits.

Keywords: Mirabegron, Derivative Spectrophotometry and ICHguidlines.