Determination of Δ4-3-ketosteroid contamination in drug base substances by CD spectroscopy - IX. Application of chiroptical methods in drug analysis

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Abstract

A very fast and selective CD spectroscopic procedure has been developed for the determination of Δ4-3-ketosteroid contamination in drug base substances. The method is based on the measurement of the intensity of the extensive, multiple negative Cotton effect in the wavelength range for the n→π* electronic transition of α,β-unsaturated ketosteroids. Examples are presented of the determination of the norethisterone acetate content of ethynodiol diacetate, and the norethisterone content of norethinodrel. The molar ellipticities of norethisterone and norethisterone acetate were determined in dioxan at the measurement wavelength of 342.8 nm. Determination of the Δ4-3-ketosteroid content at 342.8 nm is not disturbed by the base substances or their frequent "diene" or oestrogen contaminants. 0.05-5% impurity can be measured quantitatively. In this interval the ellipticity is directly proportional to the concentration.

Original languageEnglish
Pages (from-to)528-530
Number of pages3
JournalFresenius' Zeitschrift für Analytische Chemie
Volume318
Issue number7
DOIs
Publication statusPublished - Jan 1 1984

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ASJC Scopus subject areas

  • Analytical Chemistry
  • Materials Science(all)
  • Clinical Biochemistry

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