高效液相色谱法测定地氯雷他定口溶膜的溶出度和溶出曲线

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

目的采用高效液相色谱法测定地氯雷他定口溶膜的溶出度和溶出曲线。方法色谱柱:Agilent C8柱(4.6 mm×150 mm,3.5μm);流动相:乙腈-0.003 mol·L^(-1)的十二烷基硫酸钠水溶液(47∶53);流速1.5 mL·min^(-1);检测波长280 nm;进样量10μL;柱温35℃。采用桨法以0.1 mol·L^(-1)盐酸溶液、pH 4.0醋酸盐缓冲液、0.2 mol·L^(-1)氯化钠水溶液、pH 6.8磷酸盐缓冲液为溶出介质。结果地氯雷他定在0.6~6.7μg·mL^(-1)与峰面积呈良好的线性关系,回收率在100.0%~100.5%,RSD小于2.0%。地氯雷他定口溶膜在0.1 mol·L^(-1)盐酸溶液和pH 6.8磷酸盐缓冲液中累计溶出度均在85%以上,并且有较好的均一性。结论该方法简单快速、准确度高且重现性好,可实现快速测定地氯雷他定口溶膜的溶出度和溶出曲线,满足大批量样品质量控制需求。

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,3.5μm)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 10μL 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 0.6~6.7μg·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.