Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TENOFOVIR ALAFENAMIDE FUMARATE AND EMTRICITABINE IN DRUG PRODUCT

*Dr. M. David Raju

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 Trifluoroacetic acid in water: Acetonitrile: Methanol (30:10:60). The flow rate was 1.2ml/ minute and ultraviolet detector at 260nm. The average retention time for Emtricitabine and Tenofovir alafenamide fumarate found to be 2.370 min and 2.897 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, Trifluoroacetic acid, Acetonitrile, Methanol, and validation.


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