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Asian Journal of Pharmaceutical Analysis
Year : 2020, Volume : 10, Issue : 4
First page : ( 213) Last page : ( 217)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2020.00039.3

A stress degradation kinetic study of darunavir ethanolate bulk and tablet dosage form by uv spectrophotometry

Dr. Vyas Amitkumar J.1, Pandey Meenakshi M.1,*, Dr. Patel Ajay I.1, Dr. Patel Ashok B.1, Dr. Patel Nilesh K.1, Chudasama Alpesh2

1Pharmaceutical Quality Assurance Department, B. K. Mody Government Pharmacy College, Rajkot, Gujarat, India

2Amneal Pharmaceutical Pvt. Ltd., 1 New England Avenue, Piscataway, NJ, 07936, USA

*Corresponding Author E-mail: meenakshipandey1012@gmail.com

Online published on 27 April, 2021.

Abstract

This work was aimed to develop and validate simple, rapid and economical kinetic degradation method for the estimation of Darunavir ethanolate in bulk and tablet dosage form. The spectrum was determined at 267.40nm by using methanol as a solvent. The developed method was validated as per ICH guideline. Accuracy was obtained between 97.18 - 101.12%. LOD and LOQ was found to be 0.52μg/ml and 1.60μg/ml respectively. Darunavir ethanolate was subjected to acid, base, oxidation, photolytic and thermal degradation and the amount of degradation is in the range 10 - 40%. Results confirmed that this method can be employed for the estimation of Darunavir ethanolate in presence of its degradation product in tablet dosage form.

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Keywords

Darunavir ethanolate, Stress degradation, Kinetic study, UV-Spectrophotometry.

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