ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

Simultaneous determination of ciprofloxacin hydrochloride and hydrocortisone in ear drops by high performance liquid chromatography

Joanna Ronowicz, Bogumiła Kupcewicz, Łukasz Pałkowski, Piotr Bilski, Tomasz Siódmiak, Michał Piotr Marszałł, and Jerzy Krysiński

Department of Inorganic and Analytical Chemistry, Nicolaus Copernicus University, 2 Jurasza St., 85-089, Bydgoszcz, Poland

E-mail: joanna.ronowicz@cm.umk.pl

Abstract: The aim of the study was to design and validate a reversed phase high performance liquid chromatography method for the separation and quantification of two active pharmaceutical ingredients (ciprofloxacin hydrochloride, hydrocortisone) and a preservative (benzyl alcohol) in ear drops. Effective separation of the examined compounds was achieved on a GraceSmart™ RP 18 column (150 mm × 4.6 mm, 5 μm) with gradient elution and a diode array detector. The total assay run time was 25 min. Analytical method validation assays were performed. Validation parameters used for the evaluation were: specificity, linearity, trueness, precision (repeatability and reproducibility), limit of detection and limit of quantitation. Results of the validation procedure (high recoveries, good standard deviations, no interfering peaks at the retention times corresponding to the analytes) confirm that the developed chromatographic method can be applied for routine analysis of ear drops.

Keywords: ciprofloxacin hydrochloride – ear drops – high performance liquid chromatography – hydrocortisone

Full paper is available at www.springerlink.com.

DOI: 10.2478/s11696-013-0526-2

Chemical Papers 68 (7) 861–870 (2014)