Volume 20 No 9 (2022)
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RP-HPLC method development and validation for the simultaneous estimation of Mirabegron and Solifenacin succinate in pharmaceutical dosage form
Ganesh Andhale, Manish Shankarpure, Jyoti Kadam, Madhuri Shelar, Soniya Singh
Abstract
A liquid chromatographic technique for determining the combination of Mirabegron and Solifenacin
succinate has been developed and validated. The isocratic reverse phase method was used to obtain
effective chromatographic separation on a Cosmosil C18 (4.6ID X 250 mm, 5m) column. The mobile phase
employed was Methanol: Water (40:60), the pH was balanced to 3.0 by ortho phosphoric acid. The flow
rate was maintained at 0.8 mL/min and elute was monitored at 223 nm. A linear response was observed
over the concentration range 10-50 µg/mL (R2 =0.999) Mirabegron of and the concentration range 10-
50 µg/mL (R2 =0.999) of Solifenacin. The limit of quantitation (LOQ) and limit of detection (LOD) for
Mirabegron were 0.26 and 0.81 µg/mL and for Solifenacin were 0.05 and 0.1 µg/mL, respectively. The
technique was proven effectively in compliance with ICH guideline Q2. It was observed that the
percentage recovery was more than 99.0 %. The method was found to be accurate, precise, linear,
specific, sensitive, rugged, robust and stability indicating
Keywords
Mirabegron, Solifenacin succinate, validation, accuracy, HPLC
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