High Performance Liquid Chromatography (HPLC) Method Development and Validation Indicating Assay for Ciprofloxacin Hydrochloride.

ABSTRACT

A new simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid chromatography assay has been developed for the estimation of Ciprofloxacin Hydrochloride in tablet formulation. The separation was achieved by using C-18 column (LichroCART® 125x4mm, 5μm) coupled with a guard column of silica in mobile phase methanol buffer (0.025M Orthophosphoric acid with the pH adjusted to 3.0±0.1 with triethylamine) (4060v/v). The flow rate was 2.0ml/min and the drug was detected using UV detector at the wavelength of 278nm. The retention time was within 1.753 – 1.757 minutes. The method was validated as per ICH guidelines. The proposed method was found to be accurate, repeatability and consistent. It was successfully applied for the analysis of the drug in marketed formulation and could be effectively used for the routine analysis of formulation containing the drug without any alteration in the chromatography conditions.