Investigation of the temperature stability of premarin intravenous using liquid chromatography-mass spectrometry

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Abstract

Stability of Premarin®Intravenous was investigated in dry and reconstituted forms by monitoring major components in samples for a period of six months, using liquid chromatography-mass spectrometry. The components, largely comprising a series of estrogen and steroid hormone sulfates, were considered to be fairly stable (variation≤10%) for dry samples stored at room temperature and at 38°C (100°F) during the experimental time frame. However, significant variation, especially after 2 months of storage, was observed in reconstituted solutions. This variation was significantly larger for samples stored at elevated vs. room temperature. It was interesting to note that the concentration of equilenin sulfate increased over time, whereas that of other major components were seen to fluctuate and decrease. This phenomenon was partially explained by the conversion of equilin compounds into their corresponding equilenin forms, a phenomenon which was further investigated through a storage study with pure standard solutions and by tandem mass spectrometry.

Original languageEnglish (US)
Pages (from-to)1218-1222
Number of pages5
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume55
Issue number5
DOIs
Publication statusPublished - Jul 15 2011

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Keywords

  • Fragmentation
  • Premarin
  • Tandem mass spectrometry
  • Temperature stability

ASJC Scopus subject areas

  • Analytical Chemistry
  • Drug Discovery
  • Pharmaceutical Science
  • Spectroscopy
  • Clinical Biochemistry

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