HPLC法测定沙利度胺片中有关物质的含量

Content Determination of Related Substances in Thalidomide Tablets by HPLC

目的:建立沙利度胺片有关物质含量的测定方法。方法:采用高效液相色谱法,以邻苯二甲酸作为有关物质检查的对照品,测定4批样品中的有关物质含量。色谱柱为Waters Nova-Pak C18;流动相为水-乙腈-磷酸(梯度洗脱),流速为2mL·min-1;检测波长为218nm;柱温为40℃;进样体积为200μL。结果:邻苯二甲酸检测浓度线性范围为0.02～0.50μg·mL-1(r=0.9999,n=6),检出限为1.2ng,4批样品中最大单个杂质含量均小于0.09%,杂质总量均为0.1%。结论:本方法准确、可靠,且专属性强,可用于测定沙利度胺片中的有关物质。

OBJECTIVE：To establish a method for the content determination of related substances of Thalidomide tablets.METHODS：The contents of related substances in 4 batches of samples were determined by HPLC method with phthlic acid as control.The determination was performed on a Waters Nova-Pak C18 column with mobile phase composed of water-acetonitrile-phosphoric acid（gradient elution） at the flow rate of 2 mL·min-1.The detection wavelength was set at 218 nm and column temperature was 40 ℃.Injection volume was 200 μL.RESULTS：A good linearity was obtained in the range of 0.02～0.50 μg·mL-1（r=0.999 9,n=6） for phthlic acid.LOD was 1.2 ng.The contents of maximum single impurity in 4 batches of samples were all lower than 0.09% and total amount of impurity of 0.1%.CONCLUSION：The method is accurate,reliable and specific,and it is suitable for the determination of related substances of Thalidomide tablets.