An OPLC purity test suitable for routine analysis of norethisterone bulk drug substance and in tablets has been developed. Separation was performed on a fine-particle silica gel adsorbent layer by continuous development with n -hexane and butyl acetate-chloroform, 85 + 15 ( v/v ), as mobile phases. Visualization of the chromatogram by use of sulfuric acid enables detection of less than 0.05% of possible impurities by use of long-wave UV illumination. The selectivity and efficiency of this OPLC method were compared with those of the pharmacopeial TLC methods and those of HPLC method.
B. Bagócsi, D. Fábián, A. Laukó, M. Mezei, S. Mahó, Z. Végh , and K. Ferenczi-Fodor , J. Planar Chromatogr. 15 (2002) 252–257.
Ferenczi-Fodor K. , '' (2002 ) 15 J. Planar Chromatogr. : 252 -257 .
European Pharmacopoeia, 4th edn, Council of Europe, Strasbourg, 2001 p. 1646.
The United States Pharmacopoeia 26th edn, USP Convention, Rockville, MD, 2002, p. 1328.
The Japanese Pharmacopoeia 14th edn, Soc. Jap. Pharm., Tokyo, 2001, p. 650.
E. Tyihák and E. Mincsovics , Overpressured Layer Chromatography (Optimum Performance Laminar Chromatography) (OPLC). In: Sz. Nyiredy (Ed.) Planar Chromatography — A Retrospective View for the Third Millennium, Springer, Budapest, 2001, pp. 137–176.
Mincsovics E. , '', in Planar Chromatography — A Retrospective View for the Third Millennium , (2001 ) -.
B. Bagócsi, G. Rippel, Z. Végh, S. Mahó , and K. Ferenczi-Fodor , in: Sz. Nyiredy (Ed.) Proc. Int. Symp. Planar Separations — Planar Chromatography 2000, Lillafüred, Hungary, June 2000, Research Institute Medicinal Plants, Budakalász, Hungary, pp. 151–156.
Ferenczi-Fodor K. , '', in Proc. Int. Symp. Planar Separations — Planar Chromatography 2000, Lillafüred, Hungary , (2000 ) -.
B. Bagócsi, D. Fábián, M. Mezei, S. Mahó, Z. Végh , and K. Ferenczi-Fodor , 11th Int. Symp. Pharmaceutical and Biomedical Analysis, May 14–18, 2000, Basel, Switzerland. Abstracts book P 019.