Dissolution test for citalopram in tablets and comparison of in vitro dissolution profiles.

摘要

A dissolution test for tablets containing 20 mg of citalopram was developed and validated using a reverse-phase liquid chromatographic method and this dissolution test was applied to compare dissolution profiles. The sink conditions, filters, stability of the drug and specificity on different dissolution media were tested to choose a discriminatory dissolution method which uses USP apparatus 1 with baskets rotating at 50 rpm, 900 ml of deaerated 0.1 M hydrochloric acid (HCl) as the dissolution medium. The quantitation method was also adapted and validated. The parameters of difference factor, similar factor, according to current FDA guidelines, and dissolution efficiency were employed to compare dissolution profiles. The dissolution test developed and validated was adequate for its purposes and could be applied for quality control of citalopram tablets, since there is no monograph to citalopram in tablets, this work can be used to help pharmocopoeias.