黄体酮药物中一种新的杂质的高效液相色谱测定法  

Determination of A New Impurity in Progesterone by HPLC

作　　者：唐恒胜[1] 刘文英[1] 盛龙生[2] 马仁玲[2] 周红华[2] 

机构地区：[1]中国药科大学药物分析学教研室,南京210009 [2]中国药科大学分析测试中心,南京210009

出　　处：《中国药科大学学报》2005年第1期44-47,共4页Journal of China Pharmaceutical University

摘　　要：目的 :建立新的测定黄体酮中有关物质的高效液相色谱法 ,并对杂质的类别进行初步确定。方法 :在中国药典和英国药典收载的黄体酮质量标准的基础上 ,对流动相系统进行了优化 ;用高效液相色谱梯度洗脱法完成了黄体酮及有关物质的分离 ,并通过LC -MS对可能的杂质进行了初步确定。结果 :本文建立的方法可使各有关物质较好的分离 ,分离的新杂质与欧洲药典上“可能的杂质”项下的一个杂质基本吻合。结论 :本法快速、准确 ,适用于黄体酮中有关物质的分析 ,并优于中国药典法。AIM:To compare the pharmacopoeia methods determining progesterone in different countries.A new impurity was found.A new HPLC method to determine the impurities in progesterone was established. METHOD:On the basis of ChP and BP methods, the mobile phase system was optimized. Gradient elution was applied in the separation of progesterone and its related substances, and the impurities were tentatively identified by LC-MS. RESULT:In comparison with the current methods of various countries pharmacopoeia,the related substances can be better separated, and the impurities are consistent with the “possible impurities” of Europe Pharmacopoeia. CONCLUSION:Progesterone and its related substances can be determined more accurately and rapidly by the above-mentioned method.

关 键 词：黄体酮 有关物质 高效液相色谱法 梯度洗脱 LC—MS 

分 类 号：TQ464[化学工程—制药化工]