Determination of dissolution and dissolution profile of desloratadine oral soluble film by HPLC
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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