Development and Validation of a Gradient RP-HPLC Method for Concurrent Analysis of Mirabegron and Silodosin in Bulk and Pharmaceutical Tablets

Objectives

To quickly and easily identify and quantify Mirabegron and Silodosin in both pure and pharmaceutical dosage forms, a gradient Reverse-Phase High Performance Liquid Chromatography (RP-HPLC) technique was described.

Materials and Methods

The separation was accomplished using a gradient mode pumping mobile phase consisting of acetonitrile and a 0.03 M buffer (Potassium dihydrogen orthophosphate in water with pH corrected to 3.2 with orthophosphoric acid) at a flow rate of 1 mL/min on a C-18 matrix Inertsil ODS-3V column with dimensions 250x4.6 mm and a 5-micron particle size.

Results

At 6.052 and 7.986 minutes, respectively, the UV detector set at 245 nm was able to capture the peaks of MGB and SLD. The approach demonstrated linearity for MGB from 5 to 60 µg/mL and for SLD from 0.8 to 9.6 µg/mL, with matching r² values of 1 and 0.9999, respectively. A %RSD below 2 indicates that the procedure is both accurate and precise.

Conclusion

It was concluded that the approach that was developed could be utilized for routine analysis of the pharmaceuticals in question in quality control laboratories, and that it was successfully applied to simultaneously estimate MGB and SLD in pure and its commercial medicinal dosage forms.