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 C18 ODS Hypersil column of 150 × 4.6 mm id with 5 µm 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 µg 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.

Muhammad Ashraf, Hafiz Muhammad Nauman Shabbir, Muhammad Munawar Hayat, Jameel Rahman, Samina Ejaz, Muhammad Iqbal and Faiz-ul-Hassan Nasim