ABSTRACT
Objective To evaluate the similarity of dissolution behavior in vitro of self-made and reference listed drug(RLD) of esomeprazole magnesium enteric tablets. Methods The dissolution test method and HPLC method were established according to Chinese pharmacopoeia. The HPLC method was validated according to ICH guidance. The dissolution behavior of the 3 batches of the self-made drug and RLD were compared in dissolution medium of pH 1.2 HCl solutuion,pH 4.5 phosphate buffer,pH 6.8 phosphate buffer,pH 1.2 HCl solutuion(2 h)and pH 6.0 phosphate buffer,pH 1.2 HCl solutuion(2 h)and pH 6.8 phosphate buffer,and puri?fied water with different rotation rates. Results The HPLC validation results for linearity,repeatability,recovery,etc. all met the re?quirement. The similarity factors F2 between the self-made drug and RLD were greater than 50 in different dissolution mediums. Con?clusion The dissolution behaviors of the self-made drug and RLD are similar.