Biomaterial Database

Determination of ethinyl estradiol in solid dosage forms by high-performance liquid chromatography. 1982

S H Strusiak, and J G Hoogerheide, and M S Gardner

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%.

UI	MeSH Term	Description	Entries
D008777	Methyltestosterone	A synthetic hormone used for androgen replacement therapy and as an hormonal antineoplastic agent (ANTINEOPLASTIC AGENTS, HORMONAL).	17 beta Methyltestosterone,17 beta-Hydroxy-17-methyl-4-androsten-3-one,17 beta-Methyltestosterone,17-Epimethyltestosterone,17-alpha-Methyltestosterone,17alpha-Methyl-Testosterone,17alpha-Methyltestosterone,17beta-Hydroxy-17-methyl-4-androsten-3-one,17beta-Methyltestosterone,Android (Methyltestoterone),Android-10,Android-25,Android-5,Mesteron,Mesterone,Metandren,Methitest,Oreton,Testoviron,Testred,Virilon,17 Epimethyltestosterone,17 alpha Methyltestosterone,17 beta Hydroxy 17 methyl 4 androsten 3 one,17alpha Methyl Testosterone,17alpha Methyltestosterone,17beta Hydroxy 17 methyl 4 androsten 3 one,17beta Methyltestosterone,Android 10,Android 25,Android 5
D002851	Chromatography, High Pressure Liquid	Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed.	Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D004355	Drug Stability	The chemical and physical integrity of a pharmaceutical product.	Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D004997	Ethinyl Estradiol	A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.	19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17alpha)-,Ethynyl Estradiol,Estinyl,Ethinyl Estradiol Hemihydrate,Ethinyl Estradiol, (8 alpha)-Isomer,Ethinyl Estradiol, (8 alpha,17 alpha)-Isomer,Ethinyl Estradiol, (8 alpha,9 beta,13 alpha,14 beta)-Isomer,Ethinyl Estradiol, (9 beta,17 alpha)-Isomer,Ethinyl-Oestradiol Effik,Ethinylestradiol Jenapharm,Ethinyloestradiol,Lynoral,Microfollin,Microfollin Forte,Progynon C,Estradiol, Ethinyl,Estradiol, Ethynyl,Ethinyl Oestradiol Effik,Hemihydrate, Ethinyl Estradiol,Jenapharm, Ethinylestradiol
D012995	Solubility	The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)	Solubilities
D013607	Tablets	Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)	Tablet