Evaluation of tetracycline raw materials and finished products found on the kenyan market

Abstract

Contents of tetracycline, its degradation products (epitetracycline, epianhydrotetracycline, anhydrotetracycline) and a fermentation impurity (2-acetyl-2-decarboxamidotetracycline) were determined in four raw materials, 12 batches of six ointment products, four eye ointment products and nine batches of five capsule products, all sampled from the Kenyan market. The analytical method was liquid chromatography on a column packed with a poly(styrenedivinyl¬benzene) material (8-um PLRP-S 100 A). All raw materials and finished products had tetracycline contents and impurity levels within the prescribed compendial limits.