Görög S, Herényi B
Chemical Works Gedeon Richter Ltd., Budapest, Hungary.
J Chromatogr. 1987 Jul 29;400:177-86. doi: 10.1016/s0021-9673(01)81611-3.
High-performance liquid chromatography (HPLC) diode-array UV-spectrophotometric detection is used for estimating impurity profiles of steroid drugs. It is shown to be a very useful first screening method for the identification of UV-active impurities and degradation products, giving a rapid answer to many questions or at least providing important initial information to complement the results obtained by other spectroscopic techniques. In this paper the estimation of the impurity profiles of ethynyloestradiol, norgestrel, and norethisterone, and of the degradation product of RGH-1113 (3-chloro-, 6,9-difluoro-11 beta,16 alpha,17 alpha,21-tetrahydroxy-1,3,5-pregnatrien-20-one 16,17-acetonide 21-acetate) will be discussed.
高效液相色谱（HPLC）二极管阵列紫外分光光度检测法用于评估甾体药物的杂质概况。结果表明，它是一种非常有用的初步筛选方法，可用于鉴定具有紫外活性的杂质和降解产物，能快速回答许多问题，或者至少提供重要的初始信息，以补充其他光谱技术所获得的结果。本文将讨论炔雌醇、炔诺孕酮和炔诺酮的杂质概况，以及RGH - 1113（3 - 氯 - 6,9 - 二氟 - 11β,16α,17α,21 - 四羟基 - 1,3,5 - 孕三烯 - 20 - 酮16,17 - 缩丙酮21 - 乙酸酯）降解产物的评估。
