高效液相色谱法测定固体剂型中的炔雌醇

Determination of ethinyl estradiol in solid dosage forms by high-performance liquid chromatography.

作者信息

Strusiak S H, Hoogerheide J G, Gardner M S

出版信息

J Pharm Sci. 1982 Jun;71(6):636-40. doi: 10.1002/jps.2600710610.

Abstract

A rapid, reproducible high-performance liquid chromatographic system for the determination of ethinyl estradiol in solid dosage forms consisting of a reversed-phase column with a mobile phase of 0.05 M aqueous KH2PO4-methyl alcohol (2:3) and fluorescence detection has been developed. This stability-indicating method is applicable to tablets containing ethinyl estradiol alone or in combination with methyltestosterone and progesterones. The procedure has been used for the determination of ethinyl estradiol in single tablets, stability samples, and dissolution medium. Recovery of drug substance added to placebo was from 97.3 to 101.5% in stability and single-tablet assays, and 95.4 to 102.2% in dissolution assays. Reproducibility studies gave relative standard deviations of 0.4-2.2%.

摘要

已开发出一种快速、可重现的高效液相色谱系统，用于测定固体剂型中的炔雌醇。该系统采用反相柱，流动相为0.05M磷酸二氢钾水溶液 - 甲醇（2:3），并进行荧光检测。这种稳定性指示方法适用于仅含炔雌醇或与甲基睾酮和孕激素组合的片剂。该方法已用于测定单片片剂、稳定性样品和溶出介质中的炔雌醇。在稳定性和单片剂分析中，添加到安慰剂中的药物回收率为97.3%至101.5%，在溶出度分析中为95.4%至102.2%。重现性研究给出的相对标准偏差为0.4 - 2.2%。