Development and Standardization of Chromatographic Technique for Quantification of Bicalutamide in Pure and Pharmaceutical Dosage Forms

Background Bicalutamide BTM is a non-steroidal antiandrogen found to be available in various pharmaceutical dosage forms. Quantitative estimation of BTM is essential in the quality control laboratories of pharmaceutical industries.Objective The present research attempts to develop optimize and stand...

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Bibliographic Details
Published inRGUHS journal of pharmaceutical sciences Vol. 11; no. 3
Main Authors V, Ramesh, D Hiremath, Ravindra, Kamble, Praveen, Kunchanur, Mahantesh, P, Prerana
Format Journal Article
LanguageEnglish
Published 2021
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Summary:Background Bicalutamide BTM is a non-steroidal antiandrogen found to be available in various pharmaceutical dosage forms. Quantitative estimation of BTM is essential in the quality control laboratories of pharmaceutical industries.Objective The present research attempts to develop optimize and standardize chromatographic methodology for quantitative estimation of BTM in its pure and pharmaceutical dosage forms. Methodology The analysis was resolved by using a mobile phase acetonitrile methanol in the ratio of 6040 vv at a flow rate of 1 mlmin on an isocratic High Performance Liquid Chromatography HPLC system consisting of SPD-20 A20AV UV-VIS detector using C18 column at a wavelength of 275 nm. The developed method was subjected for standardization as per ICH guidelines. Results The retention time was found to be 4.7 minutes. The drug showed linear response between the concentration range from 10-100 mugmL. This method was found to be selective specific and precise with RSD Relative Standard Deviation less than 2.nbsp Conclusion The reported method was found to be simple precise and accurate for quantitative estimation of BTM in bulk and pharmaceutical dosage forms and can be employed for routine quality control analysis of BTM.
ISSN:2249-2208
DOI:10.26463/rjps.11_3_2