Investigation of the chemical stability of (d-Phe6, Gln8) GnRH (1-9)-ethylamide (Folligen) by high-performance liquid chromatography

B. Szöke, Gy Kéri, M. Idei, A. Horváth, Gy Bökönyi, I. Teplán

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

The stability of a new, superactive gonadotropin hormone-releasing hormone (GnRH) analogue (d-Phe6, Gln8) GNRH (1-9)-ethylamide [Folligenj, which may be a new drug in the "GNRH family" was investigated during storage at different temperatures, both in solid (lyophilized) form and in aqueous solution. Samples stored for various periods of time were analysed for Folligen content and for degradation products using two validated reversed-phase high-performance liquid chromatographic (HPLC) methods. The HPLC technique and the calculation method applied were found to be applicable to monitoring the chemical stability and the possible degradation products of Folligen. It is concluded that under the given experimental conditions Folligen is stable (1) in lyophilized form kept at ambient temperature at least for 1 year, (2) in frozen aqueous solution kept at - 20°C for at least 11 months, (3) in sterile aqueous solution kept in a refrigerator (5-8°C) for 5 months, (4) in sterile aqueous solution kept at ambient temperature (20-25°C) for 5 weeks and (5) in sterile aqueous solution kept at 37°C for 6 days.

Original languageEnglish
Pages (from-to)121-129
Number of pages9
JournalJournal of Chromatography A
Volume547
Issue numberC
DOIs
Publication statusPublished - Jun 28 1991

ASJC Scopus subject areas

  • Analytical Chemistry
  • Biochemistry
  • Organic Chemistry

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