Development of an Convenient and Robust Analytical Technique for HPLC-based Determination of Silodosin in Capsule Formulation

Benign prostatic hyperplasia is commonly treated with silodosin, a selective 1-adrenoreceptor antagonist. The goal is to create a straightforward and accurate high performance liquid chromatographic technique for silodosin detection and validate it in accordance with ICH standards. Agilent HPLC 1260 Infinity series was used and empower software was utilized for data processing. On a Cyano; 4.6mm × 25cm; 5mm, packing USP Octadecyl Silane column, silodosin was successfully separated by using mobile phase, made up of a mixer of 4.0 pH ammonium acetate buffer: Acetonitrile: Methanol (30:30:40) at 1.0ml/min flow rate and at a wavelength of 270 nm.The silodosin responded at 3.9minutes. The validation parameters including specificity, LOD/LOQ, linearity, accuracy, precision, robustness, and solution stability, were verified for performance of the method. All the peaks were well separated and there was no interference. Correlation coefficient of silodosin was 1.00, which indicated the method maintain linearity at different concentration. In precision study, the cumulative %RSD of silodosin was 0.88. The percent recovery of the silodosin at different concentration was within the (98.0-102.0) %. When the column temperature was increased/decreased by 3°C from the real and the flow rate was increased/decreased by 0.2mL/min from the actual rate, the system suitability resolution was still within the acceptable range. The standard and sample solution were stable after 24 hours at both room temperature and 5°C temperature. For the analysis of silodosin in pharmaceutical goods, the confirmed HPLC method may be a workable analytical approach.