This method demonstrates improved accuracy in separating solifenacin and mirabegron in bulk and tablets, indicating robust application in pharmaceuticals.
The main objective of this study is to develop a new and improved RPHPLC technique. It is sensitive and accurate and to identify mirabegron, solifenacin and their differences. A C18 (AGILENT) column is used to separate the drug and impurities by chromatography. The mobile phase consisted of 0.1% OPA and 25:75% vol/vol methanol along with TEA, pH 4.2. Results showed that mirabegron and solifenacin were successfully mixed and separated with respect to retention time. Collected at 5.521 and 9.162 min, respectively, when the flow rate was changed to 0.7 mL/min and detected at 231 nm using a UV detector. This graph shows the difference between mirabegron doses of 50-250 mcg/mL and solifenacin, 5-25 mcg/mL. Solifenacin and mirabegron increased the recovery rate from 101.46% to 101.12%. The certification process is based on the International Convention on Harmonized Standards. It achieved excellent results in terms of accuracy, precision, precision, linearity, specifications, and robustness. As a result, a strategy to successfully separate and combine solifenacin and mirabegron was successfully developed. This is a valid and reliable method for routine analysis of these substances in pharmaceutical formulations.
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Godge et al. (2025) studied this question.
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