RP-HPLC Method Development and Validation for Simultaneous Estimation of Mirabegron and Silodosin in Synthetic Mixture

作者：Ashvin Dudhrejiya, Shivangi B. Pithadiya, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Hetal B. Gavit, Dhruvanshi A. Gol · 发表于：Research Journal of Pharmacy and Technology · 年份：2024 · DOI：10.52711/0974-360x.2024.00656 · 被引用次数：4 · 研究领域：Urinary Bladder and Prostate Research、Hormonal and reproductive studies、Urinary Tract Infections Management

Background: 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. Material and Method: 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. Result: 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). Conclusion: The suggested RP-HPLC technique is highly appropriate for analyzing Mirabegron and Silodosin, as it guarantees precise findings without any interference.