Validated UPLC method for the fast and sensitive determination of steroid residues in support of cleaning validation in formulation area

Szabolcs Fekete, J. Fekete, Katalin Ganzler

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

An ultra performance liquid chromatographic (UPLC) method was developed for simultaneous determination of seven steroid (dienogest, finasteride, gestodene, levonorgestrel, estradiol, ethinylestradiol, and norethisterone acetate) active pharmaceutical ingredient (API) residues. A new, generic method is presented, with which it is possible to verify the cleaning process of a steroid producing equipment line used for the production of various pharmaceuticals. The UPLC method was validated using an UPLC™ BEH C18 column with a particle size of 1.7 μm (50 mm × 2.1 mm) and acetonitrile-water (48:52, v/v) as mobile phase at a flow rate of 0.55 ml/min. Method development and method validation for cleaning control analysis are described. The rapid UPLC method is suitable for cleaning control assays within good manufacturing practices (GMP) of the pharmaceutical industry.

Original languageEnglish
Pages (from-to)833-838
Number of pages6
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume49
Issue number3
DOIs
Publication statusPublished - Apr 5 2009

Fingerprint

Cleaning
Steroids
dienogest
Liquids
Pharmaceutical Preparations
Finasteride
Levonorgestrel
Ethinyl Estradiol
Estradiol
Assays
Particle size
Flow rate
Drug Industry
Particle Size
Water
Equipment and Supplies
Industry

Keywords

  • Cleaning validation
  • High speed separation
  • Method validation
  • Steroid separation
  • UPLC

ASJC Scopus subject areas

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

Cite this

Validated UPLC method for the fast and sensitive determination of steroid residues in support of cleaning validation in formulation area. / Fekete, Szabolcs; Fekete, J.; Ganzler, Katalin.

In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 49, No. 3, 05.04.2009, p. 833-838.

Research output: Contribution to journalArticle

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