Development of a Novel Stability quoting RP-Ultra Performance Liquid Chromatography approach for Synchronous Assessment of Doravirine, Lamivudine, and Tenofovir Disproxil fumarate in Pure API Form and Tablet Dosage Based on ICH Guidelines

Author(s): Challamalla Pavani and V. Jayashree*


The concomitant measurement of Tenofovir DF, Lamivudine, and Doravirine in bulk and tablet dose form with UPLC is the subject of this study. The separation was performed using acetonitrile and 0.1% TEA buffer at pH-3 as the mobile phase on an Endoversil, C18, ODS (2.1 50 mm 1.7 m) analytical column. The eluents were identified at 260.0 nm using a PDA detector. Doravirine, Lamivudine, and Tenofovir DF were separated at 0.805, 0.326, and 0.481 min, correspondingly, under ideal conditions. Lamivudine had a 0.09 μg/mL of detection limit, Tenofovir DF had a detection limit of 0.04 μg/mL, and Doravirine had a detection limit of 0.09 μg/mL. Lamivudine had a percentage mean recovery of 99.68 percent, Tenofovir DF had a percentage mean recovery of 99.55 percent, and Doravirine had a percentage mean recovery of 100.17%. In all of the stressful settings, the percentage of deterioration was found at a very low extent. Optimized conditions were discovered to be exceptionally suitable for determining all of them concurrently in both marketed dose form and bulk form.

image 10.4303/jdar/236188

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