A Robust RP-HPLC Method for Silodosin in Bulk and Capsule Dosage Form: An Innovative Perspective on Stability Determination

Silodosin, an α-adrenoreceptorantagonist primarily prescribed for benign prostatic hyperplasia. The present investigation was aimed to establish and validate an RP-HPLC method to ensure stability assessment, applicable for quantifying the substance in bulk as well as capsule formulations. The USFDA approved this medication in August 2008 due to its high uroselectivity, specifically targeting the prostate. The RP-HPLC method was developed using a mobile phase Acetonitrile: Triethylamine buffer pH 4.6: Methanol (70:20:10) at a flow rate of 1ml/min. The retention time was 2.44 min. The validation procedures adhered to ICH guidelines. The method exhibited a linear response within the 10-50μg∕ml range, demonstrating a regression coefficient of 0.999. The average percentage assay was determined to be within the range of 99.00-99.9%, validating the method. The percentage relative standard deviation (%RSD) remained below 2%. Stress studies revealed no note worthy alterations in drug retention times, and additional peaks were observed during degradation conditions. This validated RP-HPLC method is deemed suitable for routine analysis and quantification of Silodosin in both its bulk and capsule dosage, providing a reliable method to determine drug content and degraded products.