RP-HPLC Method for Simultaneous Estimation of Ciprofloxacin and Phenylephrine in Combined Dosage Forms

Abstract

A new, simple, rapid, selective, precise and accurate gradient RP-HPLC method has been developed for simultaneous estimation of Ciprofloxacin and Phenylephrine Hydrochloride in combined dosage form. The separation was achieved by using Thermic Hypersil C column (250 mm x 4.6 mm, 5 µm particle size) coupled with a guard column of same material, in mobile phase Acetonitrile: Methanol: Phosphate Buffer pH 6 (10: 65: 25, v/v/v). The flow rate was 1.0 ml/min and the separated drugs were detected using UV detector at the wavelength of 220 nm. The analysis was performed at room temperature (37 ± 2 ºC). The retention time of Ciprofloxacin and Phenylephrine Hydrochloride was noted to be 6.63 and 4.49 min, respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The calibration curves were linear (r2 > 0.9980) over a concentration range from 0.5 – 4.0 μg/ml and 2.0 – 5.5 μg/ml for Ciprofloxacin and Phenylephrine Hydrochloride, respectively. The relative standard deviation (RSD) was < 2.0% and the mean recovery was 100.51 ± 0.34 and 100.81 ± 0.80 for Ciprofloxacin and Phenylephrine Hydro-chloride, respectively. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations containing any one of the above drugs, or a combination, without any alteration in the chromatographic conditions.