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Development And Validation Of In-Vitro Dissolution Method For Estimation Of Emtricitabine, Tenofovir Disoproxil Fumarate And Efavirenz In Tablet Dosage Form by UHPLC.
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| Author:
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NIMIT VASA, DR.BHAVESH PATEL, PARTH PATEL, SAGAR SOLANKI
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| Abstract:
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A simple, accurate and precise UHPLC method was developed and validated for In-vitro dissolution testing of Emtricitabine, Tenofovir disoproxil fumarate and Efavirenz in tablet dosage form. The separation was achieved under optimized chromatographic condition on an Waters Sunfire C18, 50x4.6mm, 3.5 µm column with mobile phase consist 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 262 nm. The retention time for Emtricitabine, Tenofovir disoproxil fumarate and Efavirenz were about 1.581, 4.405 and 5.881 min respectively. The linearity was found to be in the concentration range of 40-240 µg/mL for Emtricitabine and 60-360 µg/mL for Tenofovir disoproxil fumarate and 120-720 µg/mL for Efavirenz. The % recoveries at 20%, 50%, 100% and 120% were found to be within the limit of 95-105%. The method was validated as per ICH and USP guideline 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, Dissolution, UHPLC
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.660
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| Download:
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