Development and Validation of HPLC Method for the Estimation of Emtricitabine in Capsule Dosage Form

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of emtricitabine in capsule dosage form. A Phenomenex (Torrance, CA) C8 column, 250× 4.6 mm id, column, at ambient temperature with mobile phase consisting of 0.03M potassium dihydrogen phosphate (pH 4.86±0.02): Acetonitrile: Methanol (40:20:40 v/v/v) was used. The flow rate was 1 mL/min and the effluent was monitored at 260 nm. The retention time was 2.95 min. The detector response was linear in the concentration of 8-60 μg/mL. The respective linear regression equation being Y=27675x+41556. The limit of detection and limit of quantification was 0.06 and 0.20μg/mL respectively. The percentage assay of emtricitabine was 100.53%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of emtricitabine in bulk drug and in its pharmaceutical dosage form.