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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
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| Author:
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NIMIT VASA, BHAVESH PATEL, PARTH PATEL, DR.BHUPATSINH VIHOL, DR.SAGAR SOLANKI
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| Abstract:
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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.
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| Keyword:
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Emtricitabine, Tenofovir Disoproxil Fumarate, Efavirenz, Degradation products, Force degradation study, UHPLC.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.423
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| Download:
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