盐酸决奈达隆片溶出度测定

Dissolution Determination of Dronedarone Hydrochloride Tablets

目的:建立盐酸决奈达隆片的溶出度检查方法。方法:溶出方法采用《中国药典》溶出度第二法,以醋酸-醋酸钠缓冲液(pH4.5)1 000 ml为溶出介质,转速:75 r·min^(-1);含量测定采用HPLC法,色谱柱为ODS色谱柱(150 mm×4.6 mm,5μm),以甲醇-乙腈-磷酸盐缓冲溶液(32:50:18)为流动相,检测波长为220 nm,柱温为40℃,流速为1.5 m·min^(-1)。结果:盐酸决奈达隆浓度在5.2～103.0μg·ml^(-1)范围内与峰面积呈良好线性关系(r=0.999 9),平均回收率是99.9%,RSD为0.2%(n=9),绘制的溶出曲线表明45 min内盐酸决奈达隆片可溶出80%以上,确定的溶出时间为45 min,限度为80%。结论:所建立的方法专属性好,操作简便,可用于盐酸决奈达隆片溶出度的检查。

Objective：To establish a determination method for the dissolution of dronedarone hydrochloride tablets.Method：The dissolution was determined by the second method described in ChP 2010.The medium was 1000 ml ethylic acid-sodium acetate buffer solution（pH=4.5）,and the rotation speed was 75 r·min-1.HPLC was performed on an ODS column（250mm×4.6 mm,5μm） with the mobile phase of methanol-acetonitrile-phosphate buffer solution（32：50：18） at the flow rate of 1.5 ml·min-1.The UV detection wavelength was 220 nm with the column temperature of 40℃.Result：The calibration curve was linear within the range of 5.2- 103.0μg·ml-1（r = 0.999 9 ） for dronedarone hydrochloride.The average recovery was 99.9%with RSD of 0.2%（n = 6）.The dissolution curve showed that dronedarone hydrochloride tablets could dissolve above 80%in 45 minutes.It was confirmed that the time of dissolution was 45 minutes and the limit was 80%.Conclusion：The method is convenient and sensitive in the dissolution determination of dronedarone hydrochloride tablets.