Roos R W
J Pharm Sci. 1978 Dec;67(12):1735-9. doi: 10.1002/jps.2600671227.
A high-pressure liquid chromatographic method is described for the analysis of estrogens in pharmaceutical tablet and injectable dosage forms. In general, the estrogens are isolated, an internal standard is added, the dansyl derivatives are formed, and the dansyl estrogen solution is injected into a liquid chromatograph. Linear response is experienced between the mass of estrogen and the ratio of the estrogen peak height to the internal standard peak height, using a microparticle silica column and chloroform--n-heptane mobile phases. With fluorometric measurement, limits of detectability for ethinyl estradiol and estradiol were 0.04 and 0.05 ng, respectively. Methyltestosterone, an androgen in combination with ethinyl estradiol, was analyzed simultaneously. Commercial pharmaceutical preparations containing estrone, ethinyl estradiol, and estradiol were analyzed by the proposed method. The results indicate the method to be sensitive, reasonably precise (less than 2%), and accurate in the analysis of estrogen in dosage forms.
本文描述了一种用于分析药物片剂和注射剂剂型中雌激素的高压液相色谱法。一般来说，先分离雌激素，加入内标，形成丹磺酰衍生物，然后将丹磺酰雌激素溶液注入液相色谱仪。使用微粒硅胶柱和氯仿 - 正庚烷流动相时，雌激素质量与雌激素峰高和内标峰高之比之间呈线性响应。通过荧光测量，炔雌醇和雌二醇的检测限分别为0.04和0.05 ng。同时分析了与炔雌醇组合的雄激素甲基睾酮。采用该方法对含有雌酮、炔雌醇和雌二醇的市售药物制剂进行了分析。结果表明该方法在剂型中雌激素分析方面灵敏、精密度合理（小于2%）且准确。
