HPLC法测定仿制与原研安立生坦片的体外溶出度  

Comparison of in vitro Dissolution between Domestic and Original Ambrisentan Tablets

作　　者：陈保来[1,2] 孙霞[2] 仲艳[2] 李家春[2] 秦建平[2] 黄文哲[1] 王振中[1,2] 萧伟[1,2] 

机构地区：[1]南京中医药大学,南京210000 [2]江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《中国药房》2015年第15期2128-2130,共3页China Pharmacy

摘　　要：目的：建立测定安立生坦片体外溶出度的方法,并将安立生坦片仿制与原研药的溶出曲线进行比较。方法：采用高效液相色谱法。色谱柱为Phenomenex Gemini C18,流动相为乙腈-0.02%三氟乙酸水溶液（60∶40,V/V）,流速为1.2 ml/min,检测波长为220 nm,柱温为40℃,进样量为100μl。溶出度测定以水、0.1 mol/L盐酸溶液（p H=1.0）、醋酸盐缓冲液（p H=5.0）、磷酸盐缓冲液（p H=6.8）为溶出介质,转速为50 r/min,5-120 min分别取样。结果：安立生坦质量浓度在1.14-6.83μg/ml范围内与峰面积呈良好线性关系（r=0.999 9）;精密度、稳定性、重复性试验的RSD均〈0.3%;平均回收率为99.38%,RSD为0.50%（n=9）;在4种溶出介质中,仿制与原研安立生坦片的溶出曲线相似因子（f2）均〉50,酸值（AV）均〈15。结论：仿制与原研安立生坦片的体外溶出行为一致。该方法可用于安立生坦片仿制药的一致性评价。OBJECTIVE：To establish a method for determining the dissolution of Ambrisentan tablet in vitro,and compare the dissolution profiles between the domestic and original products.METHODS： HPLC method was adopted.The column was Phenomenex Gemini C18,mobile phase was acetonitrile-0.02% aqueous trifluoroacetic acid（60∶40,V/V）with a flow rate of 1.2ml/min,the detection wavelength was 220 nm,the column temperature was 40 ℃,the injection volume was 100 μl.The dissolution was determined in water,0.1 mol/L hydrochloric acid solution（p H=1.0）,acetate buffer（p H=5.0） and phosphate buffer（p H=6.8）with speed of 50 r/min.The samples were taked at 5 to 120 min.RESULTS： There was a good linear relationship between the quality concentration of ambrisentan and peak area in the range of 1.14-6.83 μg/ml（r=0.999 9）.RSDs of precision,stability and reproducibility tests were lower than 0.3%.The average recovery was 99.38%,RSD was 0.50%（n=9）.In 4 kinds of mediums,the value of f2 was more than 50 and the average AV value was less than 15 in domestic Ambrisentan tablets and its original product.CONCLUSIONS： The dissolution profiles of domestic Ambrisentan tablets are consistent with its original product in vitro.The method can be used for the consistency assessment of ctomestic Ambrisentan tablets.

关 键 词：安立生坦片 溶出曲线 相似因子法 AV值 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]