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 Restek 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 ra tio of 60:40 v/v. It was mixed at
a flow rate of 1 mL/min and detected at 249 nm using UV light. The column oven was heated to 45ºC, and the injection volume w as 10 ????L. Recovery
investigations confirmed the findings of the analysis. The recovery method's percentage was determined to be between 99.00 an d 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 p arameters fell inside the
permissible range. The estimated quantity of Mirabegron in the tablets was determined using this proposed approach

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