高效液相色谱法测定安立生坦片的有关物质  

RP-HPLC Assay Method for Related Substances of Ambrisentan Tablets

作　　者：王博[1] 李洪起[1] 连潇嫣[1] 孟策[1] 任晓文[2] 

机构地区：[1]天津药物研究院制剂工程中心,天津300193 [2]天津药物研究院释药技术与药代动力学国家重点实验室,天津300193

出　　处：《中国药学杂志》2015年第6期541-544,共4页Chinese Pharmaceutical Journal

摘　　要：目的建立安立生坦片有关物质的检测方法。方法采用高效液相梯度洗脱,色谱柱为Agela Venusil MP C18柱(4.6mm×250 mm,5μm),以0.02 mol·L-1磷酸二氢钾溶液(用磷酸调节p H至3.0)-乙腈(62∶38)为流动相A、乙腈为流动相B;流速为1.0 m L·min-1;检测波长为220 nm;柱温35℃。结果在酸、碱、热、氧化破坏条件下,安立生坦产生不同程度的降解,采用建立的方法可有效检出降解产物;安立生坦与各杂质分离良好,经验证该方法的专属性、线性、耐用性等良好。结论建立的方法可较好地分离、检测出安立生坦片中的各主要杂质,可用于本品有关物质的检查。OBJECTIVE To establish an HPLC method for determination of the related substances of ambrisentan tablets.METHODS Gradient elution was performed on an Agela Venusil MP C18column（ 4. 6 mm × 250 mm,5 μm）. The mixture of 0. 02mol·L^-1phosphate buffer（ p H 3. 0） and acetonitrile（ 62∶ 38） was used as mobile phase A,and acetonitrile as mobile phase B. The flow rate was 1. 0 m L·min^-1; the detection wavelength was set at 220 nm; and the column temperature was maintained at 35 ℃. RESULTS After being treated with acid,base,heat,and oxidation,ambrisentan underwent more or less degradation. The method could effectively detect the degradation products of ambrisentan; the separation of impurities was good; the method had good specificity,linearity,and durability. CONCLUSION The proposed method can be used to separate and determine the related substances of ambrisentan tablets,and is suitable for the quality control of this drug.

关 键 词：安立生坦 有关物质 高效液相梯度洗脱 杂质G 

分 类 号：R917[医药卫生—药物分析学]