摘要
Ru486(mifepriston)为一甾体类化合物,70年代中期由法国罗素·优克福公司率先研制,对于抗早孕有显著效果。目前国内Ru486合成尚处于试制阶段,未投入批量生产。
The simutaneous separation of two intermediates and their impurities of Ru486 was first achieved by HPLC within 7 min under following conditions: column, Hypersil ODS 100×4.6 I. D.; mobile phase, acetonitrile-water (40:60, V/V) with a flow rate at 1.5 ml/min; 210 nm used as the detective wavelength and chloro-nitro-diazepine as the internal standard. The regression equation of Ⅰ, Ⅱ were as follows: Ⅰ, C=-0.4563+6.5045A, r=0.9997; Ⅱ, C=-0.9532+6.6741A, r=0.9995. The recoveries of Ⅰ, Ⅱ were in the range of 99.48% to 100.7% with coefficient variation less than 1.1%. The stability tests showed that both the samples and the internal standard were stable within 24 hours. Samples synthesized under different conditions were determined by peak area nomalization and internal standard method simutaneously, the twoes proved a good correlation. Furthermore the relationship between the melting points and the corresponding contents of Ⅰ, Ⅱ was observed, thus offering some instructive advice as well as a cheaper alternative method for the optimization of the synthetic conditions of Ru486. The two methods are simple, fast and accurate, and both are suitable for the quality control of Ru486.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1992年第1期51-54,共4页
Journal of China Pharmaceutical University
