复方酚苄明片中酚苄明溶出度测定方法的建立

目的：建立复方酚苄明片的溶出度测定方法.方法：采用《中国药典》2010年版二部附录溶出度第一法,溶出介质为0.1 mol·L-1盐酸溶液900ml,采用Hypersil BDS C18色谱柱（250 mm×4.6 mm,5 μm）,乙腈-0.7％磷酸水溶液（含0.5％三乙胺）（45∶ 55）为流动相,流速为1.0 ml·min-1,检测波长为267 nm.结果：酚苄明在5～60 μg·ml-1浓度范围内线性关系良好（r =0.999 9）,平均回收率99.8％（RSD =0.9％,n=9）.结论：该方法快速简便,准确,可用于复方酚苄明片中酚苄明溶出度的测定.

Establishment of Dissolution Method for Compound Phenoxybenzamine Hydrochloride Tablets

Objective：To establish a dissolution method for compound phenoxybenzamine hydrochloride tablets.Methods：The dissolution test method Ⅰ in Chp was adopted with 900 ml of 0.1 mol · L-1 hydrochloric acid as the dissolution media.A Hypesil BDS C18 column（250 mm ×4.6 mam,5 μm） was used with acetonitrile-0.7％ phosphoric acid（containing 0.5％ triethylamine） （45∶55） as the mobile phase.The flow rate was 1.0 ml · min-1 and the detection wavelength was 267nm.Results：The linear correlation of phenoxybenzamine hydrochloride was obtained over the range of 5-60 μg · ml-1 （r =0.999 9）.The average recovery was 99.8％ （RSD =0.9％,n =9）.Conclusion：The method is rapid and simple,and can be used in the dissolution determination of compound phenoxybenzamine hydrochloride tablets.