Estimation of Entecavir in Tablet Dosage Form by RP-HPLC

Abstract

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of entecavir in tablet dosage form. A XTerra(R) C18, 250 mm × 4.6 mm, 5 μm particle size, with mobile phase consisting of water:acetonitrile in the ratio of 80:20 (v/v) was used. The flow rate was 0.8 mL/min and the effluents were monitored at 254 nm. The retention time was 3.385 min. The detector response was linear in the concentration of 2-24 mcg/mL. The respective linear regression equation being Y= 10843.972x + 7662.8569. The limit of detection and limit of quantification was 0.1mcg and 0.3 mcg/mL, respectively. The percentage assay of entecavir was 99.07 %. 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 entecavir in bulk drug and in its pharmaceutical dosage form.