Study of Related Impurities Profile by Hplc: Case of Five Samples of Fluconazole Active Pharmaceutical Ingredient

Abstract

The main objective of this work was to analysis nine drug related impurities (A-I) by High Performance Liquid Chromatography (HPLC) in five samples (F1-F5) of Fluconazole active pharmaceutical ingredient (API), collected from five pharmaceutical industries installed in Algeria. For the organic related-impurities analysis, a liquid chromatography apparatus HPLC-UV device equipped with an automatic injector and UV/Vis detector and a column (C18), deactivated for the bases, post-grafted (5 μm) and dimensions (w: 0.15 m, Ø: 4.6 mm) were used. Each sample of Fluconazole API was processed according to the related substances procedures of the European Pharmacopoeia (EP), 8 th edition. The HPLC related-impurities analysis showed that the F1, F3, F4 and F5 samples had an individual content of specified impurities (A, B and C) and unspecified impurities meeting the required standards with a total of all impurities present meeting with the standard. F2 sample had a high content of unspecified impurity 0.126 % compared to the acceptance limit and a total of impurities 0.387 % meeting the standard. This can be explained either by the sample degradation which may be due to poor storage conditions or the batch from which this sample comes wasn't well purified during the synthesis route.