Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR ALAFENAMIDE IN BULK AND TABLET DOSAGE FORM

Benzil Dudekula, Dr. C. Ravichandran, Dr. C. Ramachandraiah* and Dr. N. Devanna

ABSTRACT

New Analytical method was developed for the estimation of Emtricitabine and Tenofovir Alafenamide in drug product by liquid chromatography. The chromatographic separation was achieved on C18 column (Intersil ODS 3V, 150*4.6mm, 5μm) at ambient temperature. The separation achieved employing a mobile phase consists of Formic acid in water: Methanol(45:55). The flow rate was 1.0ml/ minute and ultra violet detector at 260nm. The average retention time for Emtricitabine and Tenofovir Alafenamide found to be 1.919min and 4.745min. 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 40-200μg/ml for Emtricitabine and 5-25μg/ml for Tenofovir Alafenamide.

Keywords: Emtricitabine and Tenofovir Alafenamide, liquid chromatography, HPLC, Intersil ODS 3V RP18, Formic acid, Methanol and validation.


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