盐酸洛美利嗪有关物质检查高效液相色谱分析条件选择  

Determination of related substances of lomerizine hydrochloride by RP-HPLC

作　　者：邹赣昌[1] 严海[1] 

机构地区：[1]武汉大学药学院,湖北武汉430072

出　　处：《临床和实验医学杂志》2006年第2期133-134,共2页Journal of Clinical and Experimental Medicine

摘　　要：目的采用高效液相色谱法,选择最佳的色谱系统,对盐酸洛美利嗪进行有关物质检查。方法采用正交设计直观分析方法,以盐酸洛美利嗪主峰的保留时间、理论塔板数、与中间体的分离度及系统压力为指标,进行多因素多水平试验,其因素包括:pH值、三乙胺水溶液浓度及甲醇的量。结果当选择流动相为甲醇:水缓冲液(三乙胺5 m l,用磷酸调节pH3.5)=7:3,中间体之间及与主峰之间分离良好,盐酸洛美利嗪主峰理论塔板数达到6762,保留时间适中为10.19 m in。结论本色谱系统能有效分离并检出盐酸洛美利嗪经酸、碱、氧化加热破坏的产物。Objective A simple reversed phase HPLC method was developed foe determinating the related substances of Lomerizine Hydrochloride. Methods Orthogonal design direct analysis was adopted in the multi - factors and multi - levels experiment, targeting the retention time of main peak,number equivalent to a theoretical plate, resolution with mid - substances and systemic pressure. The factors include in pH value, the quantity of Tyiethylamine solution and the quantity of methanol. Results An isocratic mixture of 70% （v/v） methanol and 30% （v/v） water （ 5ml Thiethylamine） to which phosphate was added to adjust pH to 3.5 was used to mobile phase, the resolution between the peak of mid - substances and main peak is good, the number equivalent to a theoretical plate amounts to 6762 and retention time is 10.19min. Conclusion The method can be used for the determination of related degradation bv acid, alkali and Hydrogen dioxide chromatogram in Lomrizine Hvdrochloride.

关 键 词：盐酸洛美利嗪 HPLC 正交设计 有关物质检查 

分 类 号：R927[医药卫生—药学]