高效液相色谱法测定他达拉非片的有关物质  

Determination of Related Substances of Tadalafil Tablet by HPLC

作　　者：石笑弋 刘轶 

机构地区：[1]湖南省药品检验研究院,长沙410001

出　　处：《海峡药学》2017年第8期44-47,共4页Strait Pharmaceutical Journal

摘　　要：目的采用高效液相色谱法测定他达拉非片的有关物质。方法采用C8柱,以0.01%三氟乙酸溶液为流动相A,乙腈为流动相B,流速为1.0m L·min^(-1),梯度洗脱;检测波长285nm。结果在该色谱条件下,杂质峰与主峰均能有效分离,杂质G与他达拉非的线性范围分别为0.016~1.614μg·m L^(-1)(r=0.9994)及0.008~0.815μg·m L^(-1)(r=0.9995),平均回收率分别为101.23%及102.65%。结论本法简便、准确,专属性强,有助于更好地控制本品的质量。OBJECTIVE To establish an HPLC method to determination related substances of Tadalafil Tab- let. METHODS The separation was performed on a Cs column,with 0. 01% trifluoroacetic acid solution as mobile phase A,acetonitrile as mobile phase B, the flow rate was 1.0mL · min-1, linear gradient elution. The detection wavelength was 285nm. RESULTS Chlorphenamine Maleate,Tadalafil and their related substances could be sepa- rated well under the chromatographic conditions. The linear ranges were 0.016-1.614μg·m L-（-1）（r=0.9994）及0.008-0.815μg·m L-（-1）（r=0.9995）for Tadalafil. Their average recoveries were 101.23% and 102.65% ,respectively. CONCLUSION The method is simple, rapid, accurate, and can be used for the qualitycontrol of Tadalafil Tablet.

关 键 词：他达拉非片 高效液相色谱法 有关物质 梯度洗脱 

分 类 号：R927[医药卫生—药学]