Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10553670 | Journal of Pharmaceutical and Biomedical Analysis | 2009 | 6 Pages |
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 Ã 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.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Szabolcs Fekete, JenÅ Fekete, Katalin Ganzler,