VALIDATED SPECTROSCOPIC METHOD FOR ESTIMATION OF MIRABEGRON BULK DRUG AND ITS DOSAGE FORM

ABSTRACT:In this work, a straightforward, accurate, and precise UV spectroscopic method wasdeveloped and validated for Mirabegron using the hydrotropy technique in both the pure andcommercial formulation.Using urea as the solvent, the absorption maximum was found at246.40 nm. At concentration ranges of 10-80 μg/mL and correlation values of 0.9992, itcomplies with Beer-Lambert's law. Less than 2% was found to be the percent RSD for bothaccuracy and precision. Findings indicated that the LOD and LOQ values were 0.99 μg/mLand 0.329 μg/mL. It was discovered that Mirabegron's percentage recoveries ranged from99.76 to 104.20%. In accordance with ICH Q2 (R1) guidelines, the suggested method wasvalidated.The developed method worked well for figuring out the dosage form and bulk drugof mirabegron.

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Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2026-01-06
DOI
https://doi.org/10.5281/zenodo.18163019
Primary Topic
Urinary Bladder and Prostate Research
Type
article
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article

VALIDATED SPECTROSCOPIC METHOD FOR ESTIMATION OF MIRABEGRON BULK DRUG AND ITS DOSAGE FORM

Swapna Battala, Maithre Lavanya, Sunkari Ashwitha
Zenodo (CERN European Organization for Nuclear Research)
Urinary Bladder and Prostate Research
article

VALIDATED SPECTROSCOPIC METHOD FOR ESTIMATION OF MIRABEGRON BULK DRUG AND ITS DOSAGE FORM

Swapna Battala, Maithre Lavanya, Sunkari Ashwitha
article en

Abstract

ABSTRACT:In this work, a straightforward, accurate, and precise UV spectroscopic method wasdeveloped and validated for Mirabegron using the hydrotropy technique in both the pure andcommercial formulation.Using urea as the solvent, the absorption maximum was found at246.40 nm. At concentration ranges of 10-80 μg/mL and correlation values of 0.9992, itcomplies with Beer-Lambert's law. Less than 2% was found to be the percent RSD for bothaccuracy and precision. Findings indicated that the LOD and LOQ values were 0.99 μg/mLand 0.329 μg/mL. It was discovered that Mirabegron's percentage recoveries ranged from99.76 to 104.20%. In accordance with ICH Q2 (R1) guidelines, the suggested method wasvalidated.The developed method worked well for figuring out the dosage form and bulk drugof mirabegron.

Zenodo (CERN European Organization for Nuclear Research)
G Pulla Reddy Dental College & Hospital (IN)
Peace, Justice and strong institutions
Openalex Percentile: Top 96%
Urinary Bladder and Prostate Research
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VALIDATED SPECTROSCOPIC METHOD FOR ESTIMATION OF MIRABEGRON BULK DRUG AND ITS DOSAGE FORM — Swapna Battala, Maithre Lavanya, Sunkari Ashwitha · Zenodo (CERN European Organization for Nuclear Research) (2026) | TGRS Research Map | TGRS