Abstract
RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE IN BULK AND COMBINED TABLET DOSAGE FORMS

Meka Srinivasa Rao* and Dr. K. Rambabu

ABSTRACT

The aim of the method was to develop and validate a rapid, sensitive and accurate method for simultaneous estimation of Emtricitabine and Tenofovir alafenamide fumarate in drug product by liquid chromatography. The chromatographic separation was achieved on Phenyl column (Eclipse XDB-Phenyl 250*4.6, 5um) at ambient temperature .The separation achieved employing a mobile phase consists of 0.1%v/v Trifluoro acetic acid in water: Methanol (30:70). The flow rate was 0.8ml/ minute and ultra violet detector at 260nm. The average retention time for Emtricitabine and Tenofovir alafenamide fumarate found to be 3.595 min and 4.669 min. The proposed method was validated for selectivity, precision, linearity and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 50.0 – 150.0μg/mL for Emtricitabine and 6.3 –18.8μg/mL of Tenofovir alafenamide fumarate.

Keywords: Emtricitabine, Tenofovir alafenamide fumarate, Isocratic, HPLC, Phenyl, Trifluoro acetic acid.


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