Abstract

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.

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