Simultaneous determination of novel prediabetic obesity drugs mirabegron and tadalafil in synthetic mixture by liquid chromatography
Abstract
Type 2 diabetes mellitus and insulin resistance are closely associated with obesity. A new drug combination mirabegron and tadalafil, currently in the clinical phase IV trials, has been shown to be effective in the improvement of glucose tolerance in prediabetic obesity. This article aimed at developing and validating an HPLC method for its quantification. An RP-HPLC method was developed using a Phenomenex C18 column (250 × 4.6 mm, 5 μm) as the stationary phase. The mobile phase consisted of methanol: water (90:10 v/v) with pH adjusted to 5 using 1% orthophosphoric acid. Methanol was the solvent, and detection was carried out at 242 nm. Validation was carried out according to ICH Q2 (R2) guidelines. The method was linear in the range of 5–25 µg/mL for tadalafil and 25–125 µg/mL for mirabegron. Retention times were 4.38 and 3.2 minutes, with a resolution of 2. %RSD values were <2 for precision, robustness, and accuracy, with recovery rates of 99.1-101.00% and 98.70-101.40% for tadalafil and mirabegron, respectively. Detection limits were 0.36 and 2.3 µg/mL, and quantitation limits were 1.1 and 6.9 µg/mL. The validated isocratic RP-HPLC method is reliable for routine quantification of mirabegron and tadalafil in synthetic mixtures for prediabetic obesity.
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