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ISSN 2063-5346
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Stability Indicating UV-Spectroscopic Method Development and Validation of Silodosin in Bulk and Capsule Dosage Form-A Green Analytical Approach

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Soumya Stuti Patnaik1, Dravidamani Meena2, Sayyad Mustak 1, Arshiya Nazneen3,Smriti Gohri4, Tiru Kondur HimaBindu Kasyap1, Ravi Kumar Vakkalagadda1, Sandip Sen1*
» doi: 10.48047/ecb/2023.12.10.726

Abstract

Silodosin is a medication for the symptomatic treatment of benign prostatic hyperplasia. It acts as an α - adrenoreceptor antagonist with high uroselectivity (selectivity for the prostate). It was approved by USFDA in August 2008. The present study was aimed to develop and validate stability indicating green UV-VIS spectrophotometric method for the estimation of Silodosin, in bulk and capsule dosage form. The UV-spectroscopic method was developed by using water and methanol (9:1). The absorption maxima (λ max) of the drug was found to be 267nm. The methods were validated as per ICH guidelines. A linear response was observed in the range of 10-50μg/ml with a regression coefficient of 0.998. The average percentage assay was calculated and found to be 99.00-99.9 %. The percentage relative standard deviation was found to be less than 2%. The stress studies showed no significant change in absorption maxima of drugs, and no interfering peaks were found under alkaline, acidic, oxidative and thermal degradation conditions.

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