安立生坦片方法学研究  

Analysis of Ambrisentan Tablets

作　　者：余继梅[1,2] 刘燕[2] 杨臻博[3] 张慧[2] 李志平[2] 梅兴国[2] 

机构地区：[1]武汉工程大学化工与制药学院,湖北武汉430070 [2]军事医学科学院毒物药物研究所,北京100850 [3]解放军322医院药剂科,山西大同037006

出　　处：《解放军药学学报》2016年第1期45-48,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：国家科技重大专项综合性新药研究开发大平台;No.2012ZX09301003-001-009

摘　　要：目的建立安立生坦溶出度、含量及有关物质测定方法,并进行方法学验证。方法含量及有关物质采用Agilent ZORBAX SB-C18色谱柱(4.6 mm×150 mm,5μm);流动相为5 mmol·L-1磷酸二氢钾(p H 2.5)-乙腈(45∶55),柱温:30℃,流速:1.0ml·min-1,检测波长为263 nm;溶出度检测波长:213 nm,其他条件不变。结果含量及有关物质线性回归方程为:A=18 673 C-27.321,r=0.9993(n=7);精密度RSD为0.48%;24 h稳定性RSD为0.78%;平均回收率为100.15%,RSD为1.04%。溶出度线性回归方程:A=75.48 C-5.73,r=0.9993(n=8);精密度RSD为1.12%;稳定性24 h为RSD为1.05%,平均回收率为99.79%,RSD为0.79%。结论本法操作简单、方法准确可靠、专属性好、灵敏度高,可用于安立生坦片的质量研究。Objective To develop a method for the determination of dissolution rate,content,related substances of ambrisentan tablets. Methods The determination was performed on Agilent ZORBAX-C18（ 150 mm ×4. 6 mm,5 μm） column,and the mobile phase was 5 mmol·L- 1phosphate buffer（ p H = 2. 5） and acetonitrile of45∶ 55 at a flow rate of 1. 0 ml·min- 1. The temperature of the column was 30 ℃ and the detection wavelength was263 nm. The detection wavelength of dissolution was changed to 213 nm,but other conditions were unchanged.Results The equation of linear regression was A = 18 673C- 27. 321,r = 0. 9993（ n = 7）,RSD of precision and stability was 0. 48% and 0. 78%,and the average recovery was 100. 15%（ RSD = 1. 04%）. For the analysis of dissolution,the equation of linear regression was A = 75. 48 C- 5. 73,r = 0. 9993（ n = 8）. RSD of precision and stability was 1. 12% and 1. 05%,while the average recovery was 99. 79%（ RSD = 0. 79%）. Conclusion This analytic method for ambrisentan is simple,accurate,specific and sensitive,so it can be used for quality evaluation of ambrisentan tablets.

关 键 词：安立生坦片 HPLC 溶出度 含量 有关物质 

分 类 号：R927.2[医药卫生—药学]