Development and Validation of RP-HPLC Method for the Determination of Adefovir Dipivoxil in Bulk and in Pharmaceutical Formulation

摘要

A rapid and sensitive RP-HPLC method with UV detection (262 nm) for routine analysis of adefovir dipivoxil in bulk and in pharmaceutical formulation was developed. Chromatography was performed with mobile phase containing a mixture of acetonitrile and phosphate buffer (50:50, v/v) with flow rate 1.0 mL min-l. In the range of 5.0-100 µg/mL, the linearity of adefovir dipivoxil shows a correlation co-efficient of 0.9999. The proposed method was validated by determining sensitivity accuracy, precision, robustness stability, specificity, selectivity and system suitability parameters.