Analysis of Drug-Related Impurties by HPLC in Ciprofloxacin Hydrochloride Raw Material.

Abstract

Objectives: In this study, we report the quality control results of drug-related impurity analysis of seven raw materials of ciprofloxacin hydrochloride marketed in Algeria.

Materials and methods: According to the European Pharmacopoeia (Eur. Ph.), high-performance liquid chromatography (HPLC) was used to analyze (B, C, D and E) impurities, while thin layer chromatography (TLC) used to control impurity A.

Results: HPLC analysis showed that the C1, C2, C3, C4, and C6 samples have individual contents of specified impurities (B, C, D, E), unspecified and the total of all present impurities conform to norms. The C5 sample contains a very high content (0.579%) of impurity C, which is a photodegradation product and the impurities total (0.625%) exceeding limit, while C7 sample has a slightly higher content (0.118%) of unspecified impurity. The control solution of impurity A was not migrated in all developed TLC plates, so the system is not compliant, for this reason, an HPLC analysis protocol was developed.

Conclusion: The results showed that impurity A content conformed in all samples except for the C6 sample, which has equal content to the limit. Therefore, we recommend revising the detecting technique of impurity A by TLC in the Eur. Ph. or replacing it with a more sensitive technique such as HPLC.