HPLC Determination of Entecavir in Pure, Tablet Dosage Form and Spiked Plasma

Entecavir is an analogue with selective activity against hepatitis B virus. In this study, an HPLC method for the determination of entecavir was developed. Entecavir was eluted through C-18 ODS Hypersil column of 150 x 4.6 mm id with 5 mu m particle size using simple mobile phase of acetonitrile: 10 mM phosphate buffer (80: 20) at a flow rate of 1.0 mL min(-1) and eluate was detected at 218 nm. Etoposide was used as an internal standard. The accuracy of the developed method was 97-99% for both with-in-batch and between-batches studies and CV (%) of < 3. The new method is highly sensitive upto 0.0097 mu g mL(-1). The validation results and statistical data demonstrate that the method is more sensitive, reliable and reproducible and has an importance in quality assurance of entecavir analysis and in bioequivalence studies.