Abstract
SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND TENOFOVIR ALAFENAMIDE FUMARATE IN BULK DRUG PRODUCT BY RP-HPLC METHOD

Meka Srinivasa Rao*, B. Sowjanya and Dr. K. Rambabu

ABSTRACT

New analytical method was developed for the estimation of Lamivudine and Tenofovir alafenamide fumarate in drug product by liquid chromatography. The chromatographic separation was achieved on C18 column (Eclipse XDB-Phenyl 250*4.6mm) at ambient temperature. The separation achieved employing a mobile phase consists of 0.1%v/v Trifluoro acetic acid in water: Methanol (300:700). The flow rate was 1.0ml/ minute and ultra violet detector at 260nm. The average retention time for Lamivudine and Tenofovir alafenamide fumarate found to be 2.412 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 300.0 – 900.00μg/ml for Lamivudine and 6.3 –18.8μg/ml of Tenofovir alafenamide fumarate.

Keywords: Lamivudine, Tenofovir alafenamide fumarate, Isocratic, HPLC, Eclipse XDB-Phenyl, Trifluoro acetic acid, Acetonitrile, Methanol and validation.


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