The Estimation of Entecavir in Tablet Dosage Form by RP-HPLC.

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Entecavir in tablet dosage form. A RP Inertsil ODS-3V C-18, 250x4.6 mm, 5μm particle size, with mobile phase consisting of 0.02M Ammonium acetate in water and Acetonitrile in the ratio of 75:25 v/v was used. The flow rate was 0.7 ml/min and the effluents were monitored at 254 nm. The retention time was 3.853 min. The detector response was linear in the concentration of 40–120μg/ml. The respective linear regression equation being Y= 76650.808X – 34291.9 the limit of detection and limit of quantification was 0.05μg and 0.15μg/ml respectively. The percentage assay of Entecavir was 98.74%. 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.