摘要
目的:为了完善尼莫地平的有关物质检查方法,使其更适用于国情。方法:合成了4种尼莫地平的杂质(impurity A、im-purity B、impurity C、杂质2);建立了以杂质对照品测定尼莫地平有关物质的方法,本法采用十八烷基硅烷键合硅胶为填充剂,甲醇-乙腈-水(15:30:55)为流动相,检测波长:237nm。结果:得到尼莫地平4种有关物质杂质纯品,光谱数据与各自结构吻合。实验测定方法中,impurity A 和 impurity B、impurity C、杂质2分别在0.1-0.5μg·mL^(-1)和1～5μg·mL^(-1)浓度范围内呈良好的线性关系,相关系数 r 分别为:0.9977,0.9999,0.9997,0.9999。各杂质平均回收率分别为98.3%,98.9%,99.2%,99.1%。结论:本方法操作简便,能够准确测定尼莫地平有关物质。
Objective：We wanted to perfect the determination method of the related substances in nimodipine, for its adaptability to our country. Method：Four related substances of nimodipine are prepared and their content was determinated by HPLC. Waters Symmetry Shield^TM C18 （3.9 mm × 150 mm,5 μm） was used with mobile phase con- sisted of methanol - acetonitrile - water （ 15： 30：55 ）. The detective wavelength was set at 237 nm. Result ：We obtained four pure products, and their spectrum data accorded with their structures. In the determination of related substances by HPLC, the linearity are good within the range 0. 1 - 0. 5 μg·mL^-1, 1 - 5 μg·mL^-1, and the regression coefficient are 0. 9977,0. 9999,0. 9997,0. 9999 respectively, while the recoveries are 98.3% , 98.9% , 99.2% ,99. 1% respectively. Conclusion：This method is operated easily,and it can be used to accurately determinate the related substances＇ contend in nimodipine.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第7期1039-1042,共4页
Chinese Journal of Pharmaceutical Analysis
作者简介
通讯作者Tel：（029）85275392；E-mail：helc@xjtu．edu.cn
