RP-HPLC法测定WF-208原料药有关物质  

RP-HPLC determination of related substances in WF-208

作　　者：崔红霞[1] 霍艳双[1] 李清[1] 李伟[1] 王曼曼[1] 陈晓辉[1] 毕开顺[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《药物分析杂志》2012年第7期1205-1208,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定噁二唑基哌嗪衍生物(WF-208)原料药有关物质的RP-HPLC方法,以控制其质量。方法:采用Dia-monsil C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈-甲醇-水,梯度洗脱;流速:1.0 mL.min-1;检测波长:238 nm;柱温:30℃。结果:WF-208能与合成过程中的2个主要中间体Ⅰ、Ⅱ和其他有关物质实现良好的分离,2个主要中间体Ⅰ、Ⅱ均在0.02～1.5 mg.L-1范围内呈良好的线性关系,检测限均为5μg.L-1。结论:本法灵敏,专属性强,可用于WF-208原料药的质量控制。Objective ： To establish an RP - HPLC method for the determination of related substances in WF - 208 （ derivative of oxadiazole piperazine）. Methods： Diamonsil ClS （ 250 mm× 4. 6 mm, 5 μm） was adopted with acetonitrile - methanol - water as the mobile phase at the flow rate of 1.0 mL .min^-1, the wavelength was set at 238 nm and the column temperature was 30 ℃. Results ： The two main intermediates of WF - 208 and other relat- ed substances were completely separated from WF - 208. The linearity of two main intermediates was in the range of 0. 02 - 1.5 mg. L^-1. The limit of determination （LOD） was 5 μg . L^- 1 Conclusion： The method is sensitive, specific and suitable for the separation and determination of related substances in WF -208.

关 键 词：反相高效液相色谱法 衍生物 噁二唑基哌嗪 杂质分析WF-208 中间体 原料药 抗癌药 酶活化剂 质量控制 有关物质 

分 类 号：R917[医药卫生—药物分析学]