Development and validation of dissolution test for Metoprolol sustained release capsules

Abstract

Dissolution test for sustained release capsules of Metoprolol 125 mg was developed and validated according to FDA and ICH guidelines. Metoprolol coated pellets were coated with microcrystalline wax and glyceryl distearate for slow release of drug. The dissolution method which uses USP apparatus I (Basket) with rotating at 100 rpm, 900 ml of different dissolution medium, ultra violet spectroscopy for quantification was demonstrated to be robust, discriminating and transferable. Dissolution tests conditions were selected after it was demonstrated that the Metoprolol rapidly dissolved in the aqueous media over the pH range of 1.2 to 7.4