Development and validation of a stability-indicating HPLC method for determination of ciprofloxacin hydrochloride and its related compounds in film-coated tablets

Abstract

The objective of the current study was the development and subsequent validation of a simple, sensitive, precise and stability-indicating reversed-phase HPLC method for the determination of ciprofloxacin HCl in pharmaceutical dosage forms in the presence of its potential impurities. The chromatographic separation of ciprofloxacin HCl and its related compounds was achieved on an Inertsil ODS3 column using UV detection. The optimized mobile phase consisted of phosphoric acid solution: acetonitril. The proposed method provided linear responses within the concentration range 250-750 pg mL(-1) for ciprofloxacin HCI and 0.5-1.5 mu g mL(-1) for its related compounds. LOD and LOQ values for the active substance were 5.159 and 15.632 mu g mL(-1), respectively. Correlation coefficients (r) of the regression equations for the impurities were greater than 0.99 in all cases. The precision of the method was demonstrated using intra- and inter-day assay RSD% values which were less than 1% in all instances. No interference from any components of pharmaceutical dosage forms or degradation products was observed.