A High-Throughput LC-MS/MS Bioanalytical Method for Simultaneous Determination of Mirabegron and Solifenacin in Pharmacokinetic Investigations.

Mirabegron, a Beta-3 adrenoceptor agonist drug, and Solifenacin succinate, an antimuscarinics drug, are used to treat overactive bladder in combination. Till today, no bioanalytical method has been reported to estimate Mirabegron and Solifenacin succinate in type of matrix. Mirabegron and Solifenacin succinate were measured in rat plasma using Darifenacin as the internal standard, a newly developed and validated bioanalytical LC-MS/MS technique. The analytes were separated using a Luna C18 column and a mobile phase combination of acetonitrile: 0.1% formic acid in HPLC water (50:50 v/v). The flow rate was maintained at an isocratic level of 1.0 mL/min, and the runtime was about 5 min. Mirabegron (m/z 397.51 to 83.78) and Solifenacin succinate (m/z 481.56 to 148.79) were determined by using the mass spectra with positive mode of multiple reaction monitoring. The strategy was approved in accordance with USFDA regulations. Accuracy with mean % recovery of 96.25% to 98.45% and 96.46% to 98.05% and strong linearity with r2 value of 0.9998 in the ranges of Mirabegron (2.5-100 ng/mL) and Solifenacin succinate (0.5-20 ng/mL) are the outcomes. All other parameters fall within the approved range. Indicators of medication effectiveness and safety, pharmacokinetic parameters, may be determined using the proposed technique.