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Semiautomated method for analysis of enteric-coated and plain coated diethylstilbestrol tablets. 1980

R E Kolinski, and J W Myrick, and E A Bunch

A semiautomated fluorometric method for the analysis of enteric-coated and plain coated diethylstilbestrol tablets is presented. To eliminate interferences from tablet excipients, diethylstilbestrol is extracted into an organic solvent and then into a basic aqueous solution. After UV irradiation, a product of diethylstilbestsrol is formed from which a fluorophore is produced chemically. The fluorescence is measured at an excitation wavelength of 335 nm and an emission wavelength of 410 nm. The coefficient of variation measured for the semiautomated procedure was 0.59%. Assay results agreed well with the USP procedure for tablets containing greater than 1 mg of diethylstilbestrol. Tablet dyes and excipients interfered in the USP procedure, which yielded low results for tablets containing less than 1 mg of diethylstilbestrol. Standard recovery data and assays of tablet composites showed that dyes and other excipients do not interfere with semiautomated procedure.

UI MeSH Term Description Entries
D004054 Diethylstilbestrol A synthetic nonsteroidal estrogen used in the treatment of menopausal and postmenopausal disorders. It was also used formerly as a growth promoter in animals. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), diethylstilbestrol has been listed as a known carcinogen. (Merck, 11th ed) Stilbestrol,Agostilben,Apstil,Diethylstilbestrol, (Z)-Isomer,Diethylstilbestrol, Disodium Salt,Distilbène,Stilbene Estrogen,Tampovagan,Estrogen, Stilbene
D001322 Autoanalysis Method of analyzing chemicals using automation. Autoanalyses
D013050 Spectrometry, Fluorescence Measurement of the intensity and quality of fluorescence. Fluorescence Spectrophotometry,Fluorescence Spectroscopy,Spectrofluorometry,Fluorescence Spectrometry,Spectrophotometry, Fluorescence,Spectroscopy, Fluorescence
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
D013608 Tablets, Enteric-Coated Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed) Enteric-Coated Tablets,Tablets, Enteric Coated

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