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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第7期1205-1208,共4页
Chinese Journal of Pharmaceutical Analysis
