simple and specific stability- indicating RP-HPLC method for routine assay of adefovir dipivoxil in bulk and tablet dosage form

ABSTRACT

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 C[18] column using a mixture of acetonitrile-citrate buffer [10 mM at pH 5.2] 3664 [%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 micro g/mL; the regression coefficient was 0.9999 and the linear regression equation was y = 24844x-2941.3. The detection [LOD] and quantification [LOQ] limits were 0.12 and 0.35 micro g/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