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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Stability Indicating UHPLC Method for Assay Content Determination of Emtricitabine, Tenofovir Disoproxil Fumarate and Efavirenz in Presence of Its Degradation Products in Bulk and Pharmaceutical Dosage Form

Author: NIMIT VASA, BHAVESH PATEL, PARTH PATEL, DR.BHUPATSINH VIHOL, DR.SAGAR SOLANKI
Abstract: A simple, accurate and precise stability indicating UHPLC method was developed and validated for assay content determination of Emtricitabine, Tenofovir disoproxil fumarate and Efavirenz in presence of its degradation products in Bulk and Pharmaceutical dosage form. The separation was achieved under optimized chromatographic condition on an Waters Sunfire C18, 50x4.6mm, 2.5 µm column with mobile phase consisting of 20mM Potassium dihydrogen phosphate buffer pH 3.0±-0.05: Acetonitrile: Methanol with gradient elution at a flow rate of 1.6 mL/min using 35°C column oven temperature with UV detection at 264 nm. The retention time for Emtricitabine, Tenofovir disoproxil fumarate and Efavirenz were about 1.6, 4.5 and 5.9 minutes respectively. The linearity was found to be in the concentration range of 50-150 µg/mL for Emtricitabine (FTC), 75-225 µg/mL for Tenofovir disoproxil fumarate (TDF) and 150-450 µg/mL for Efavirenz (EFV). The % recoveries at 50%, 100% and 150% were found to be within the limit of 98-102%. FTC, TDF and EFV and their combination drug products were subjected to acid, base, oxidation, dry heat, heat/humidity and photolytic stress conditions; the stressed samples were analyzed by the proposed method. The method was validated as per ICH and USP guidelines; and the values were found to be within the limits. So, the proposed method was found to be simple, linear, accurate, precise, robust and specific.
Keyword: Emtricitabine, Tenofovir Disoproxil Fumarate, Efavirenz, Degradation products, Force degradation study, UHPLC.
DOI: https://doi.org/10.31838/ijpr/2021.13.02.423
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