Mirabegron Quantitative Estimation in Extended-Release Tablets: A New RP-HPLC Method and Its Validation

• Mehdi Rezaei

  English

  Author

• Ali Ramazani

  English

  Author

This work details and validates a sensitive and fast technique for RP-HPLC analysis of Mirabegron in Extended-Release tablets. In
the concentration range of 10 to 100 μg/mL, the HPLC test technique was determined to be linear. Isocratic elution on a Reste k C18
column (250 mm × 4.6 mm, 5μm) was used to successfully accomplish separation. The mobile phase was a mixture of acetonitrile
and potassium dihydrogen phosphate at a ratio of 60:40 v/v. It was mixed at a flow rate of 1 mL/min and detected at 249 nm us ing
UV light. The column oven was heated to 45ºC, and the injection volume was 10 ????L. Recovery investigations confirmed the findings
of the analysis. The recovery method's percentage was determined to be between 99.00 and 101.17%. A limit of detection (LOD) of
0.015 μg/mL and a limit of quantification (LOQ) of 0.049 μg/mL were determined. Every single one of the validation parameters fell
inside the permissible range. The estimated quantity of Mirabegron in the tablets was determined using this proposed approach .

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