Determination of Elemental Impurities Ciprofloxacin hydrochloride and Fluconazole via ICP-OES

In this paper, we report the results of quality control based in elemental impurities determination of 12 raw materials samples of Ciprofloxacin hydrochloride and Fluconazole intended for the manufacture of their generic products marketed in Algeria. These samples were supplied by different pharmaceuticals companies. Heavy metals limit test and Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) were used to control and quantify the elemental impurities in these samples. The limit tests results showed that all samples were conformers except F5 sample. The ICP-OES analysis showed that the content of each element is normal in all samples except Cobalt content is greater than the limit required in C4 sample. The highlighting of certain elemental impurties exceeds safety standards confirm that heavy metals test is neither specific nor exact, so it’s recommended to apply the new procedures based on safety data which are well described in the USP new chapters or the Eur Ph general chapter.

Keywords:

Elemental Impurities , ICP-OES , Ciprofloxacin Hydrochloride , Fluconazole