a simple and specific stability- indicating rp-hplc method for routine assay of adefovir dipivoxil in bulk and tablet dosage form

a simple and reliable stability-indicating rp-hplc method was developed and validated for analysis of adefovir dipivoxil (adv).the chromatographic separation was performed on a c18 column using a mixture of acetonitrile-citrate buffer (10 mm at ph 5.2) 36:64 (%v/v) as mobile phase, at a flow rate of 1.5 ml/min. detection was carried out at 260 nm and a sharp peak was obtained for adv at a retention time of 5.8 ± 0.01 min. no interferences were observed from its stress degradation products. the method was validated according to the international guidelines. linear regression analysis of data for the calibration plot showed a linear relationship between peak area and concentration over the range of 0.5–16 μg/ml; the regression coefficient was 0.9999and the linear regression equation was y=24844x–2941.3. the detection (lod) and quantification (loq) limits were 0.12 and 0.35 μg/ml, respectively. the results proved the method was fast (analysis time less than 7 min), precise, reproducible, and accurate for analysis of adv over a wide range of concentration. the proposed specific method was used for routine quantification of adv in pharmaceutical bulk and a tablet dosage form.