2016•Der pharmacia lettreRequires access

Validated UV spectrophotometric method for quantitative determination ofMirabegron in bulk and Pharmaceutical dosage form

Panchumarthy Ravisankar, V. Sree Vidya, Pinnamraju Durga Nithya, P. Srinivasa Babu

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Abstract

In the present work simple, precise, specific, accurate and cost effective UV spectrophotometric method has been developed for the determination of Mirabegron in pure and pharmaceutical formulation. The wavelength of the Mirabegron detection was 251 nm using methanol as a solvent and obeys Beer’s law in the concentration range of 0.2 – 1.2 μg /mL with a correlation coefficient of 0.9991. Relative standard deviation of both intraday and interday precision were less than 2%. The LOD and LOQ were found to be 0.00957 μg/mL and 0.02900 μg/mL. Moreover, recovery of Mirabegron in tablet formulation was found to be in the range of 99.63-100.45 %. The applicability of the method was demonstrated by determining the drug content in pharmaceutical formulation where it exhibited good recovery. The Proposed spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The developed method was successfully applied for the determination of Mirabegron in bulk form and pharmaceutical formulations.

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In the present work simple, precise, specific, accurate and cost effective UV spectrophotometric method has been developed for the determination of Mirabegron in pure and pharmaceutical formulation. The wavelength of the Mirabegron detection was 251 nm using methanol as a solvent and obeys Beer’s law in the concentration range of 0.2 – 1.2 μg /mL with a correlation coefficient of 0.9991. Relative standard deviation of both intraday and interday precision were less than 2%. The LOD and LOQ were found to be 0.00957 μg/mL and 0.02900 μg/mL. Moreover, recovery of Mirabegron in tablet formulation was found to be in the range of 99.63-100.45 %. The applicability of the method was demonstrated by determining the drug content in pharmaceutical formulation where it exhibited good recovery. The Proposed spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The developed method was successfully applied for the determination of Mirabegron in bulk form and pharmaceutical formulations.

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Available abstract

In the present work simple, precise, specific, accurate and cost effective UV spectrophotometric method has been developed for the determination of Mirabegron in pure and pharmaceutical formulation. The wavelength of the Mirabegron detection was 251 nm using methanol as a solvent and obeys Beer’s law in the concentration range of 0.2 – 1.2 μg /mL with a correlation coefficient of 0.9991. Relative standard deviation of both intraday and interday precision were less than 2%. The LOD and LOQ were found to be 0.00957 μg/mL and 0.02900 μg/mL. Moreover, recovery of Mirabegron in tablet formulation was found to be in the range of 99.63-100.45 %. The applicability of the method was demonstrated by determining the drug content in pharmaceutical formulation where it exhibited good recovery. The Proposed spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The developed method was successfully applied for the determination of Mirabegron in bulk form and pharmaceutical formulations.

Key concepts: Mirabegron, Dosage form, Chromatography, Relative standard deviation, Pharmaceutical formulation, Solvent, Chemistry, Materials science

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