RP-HPLC method development and validation for simultaneous estimation of mirabegron and silodosin in synthetic mixture

The primary objective of the present study of RP-HPLC technique by utilizing a UV detector that possesses characteristics of simplicity, sensitivity, speed, accuracy, and precision. The present study employed a methodology to concurrently determine the quantities of Mirabegron and silodosin within a synthetic blend.

RP-HPLC Method was developed by using isocratic elution mode. Using an OROSIL C₁₈ column that measured 150mm in length, 4.6mm in Column inside Diameter (ID), and 3μm in particle size, the materials were separated by liquid chromatography. The mobile phase employed was a blend of methanol and phosphate buffer at a 60:40% v/v ratio. And 0.5ml/min wasflowing rate, the separation was accomplished. Using a UV detector, all of the compounds were identified and measured at a wavelength of 270nm.

For Mirabegron and Silodosin, the linearity of the technique was seen within the range of concentration for 6.3-150 ppmand 2-48μg/ml, respectively. The range of percentage recovery for Silodosin was 98.05% to 100.23%, and for Mirabegron it was 98.86% to 100.64%. The methodology was verified in compliance with the International Council on Harmonization's criteria (Q2R1).

The suggested RP-HPLC technique is highly appropriate for analyzing Mirabegron and Silodosin, as it guarantees precise findings without any interference.