Objective To determine the dissolution and dissolution profile of desloratadine in desloratadine oral soluble film by HPLC.Methods HPLC was performed on Agilent C8 column(4.6 mm×150 mm,3.5 μm)with the mobile phase of acetonitrile-0.003 mol·L-1 aqueous sodium dodecyl sulfate solution(47∶53)at a flow rate of 1.5 mL·min-1.The analytes were detected at 280 nm.The injection volume was 10 μL and the column temperature was 35℃.In the dissolution expermient,0.1 mol·L-1 hydrochloric acid,acetate buffer pH 4.0,0.2 mol·L-1 sodium chloride solution and phosphate buffer pH 6.8 as dissolution media with paddle manipulation were used.Results The desloratadine showed good linearity at 0.6～6.7 μg·mL-1.The recovery ranged 100.0%～100.5%,and the RSD was less than 2.0%.The cumulative dissolution of desloratadine oral soluble film in 0.1 mol·L-1 hydrochloric acid solution and phosphate buffer pH 6.8 was over 85%with good uniformity.Conclusion The method is simple,rapid,accurate and reproducible.It can rapidly determine the dissolution and dissolution profile of desloratadine in desloratadine oral soluble film.
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