McErlane K M, Curran N M
J Pharm Sci. 1977 Apr;66(4):523-6. doi: 10.1002/jps.2600660415.
A procedure is described for the enzyme hydrolysis and GLC assay of conjugated estrogens in commercial formulations. Resolution of up to nine of the components is achieved on a methyl phenyl cyanopropyl silicone-coated column using a dual-derivatization and dual-injection technique. Replicate results from analyses of a commercial tablet formulation yielded coefficients of variation between 1.0 and 17.2%, depending mainly on the quantity present; a coefficient of variation of 0.4% was obtained for the assay for total conjugated estrogens. Similar results were obtained with other commercial formulations.
本文描述了一种用于商业制剂中结合雌激素的酶水解和气相色谱分析的方法。使用双衍生化和双进样技术,在甲基苯基氰丙基硅氧烷涂层柱上可实现多达九种成分的分离。对一种商业片剂制剂的分析结果表明,重复分析的变异系数在1.0%至17.2%之间,主要取决于含量;总结合雌激素测定的变异系数为0.4%。其他商业制剂也得到了类似的结果。