Development and Validation of an RP-HPLC Method for Quantitative Monitoring of Ciprofloxacin Formulations

International Journal of Chemistry | Vol. 5, No. 5, May 2014 | pp. 33–40

DOI: 10.46882/2014/IJC/000068

Article Type: Original Research Paper

Title: Development and Validation of an RP-HPLC Method for Quantitative Monitoring of Ciprofloxacin Formulations

Names of Authors: E. O. Effiong¹, A. G. Silva²*

Authors’ Affiliations:
¹Department of Chemistry, University of Uyo, Uyo, Nigeria.
²Department of Pharmacy, University of Porto, Porto, Portugal.

Abstract: Developing simple, automated, and accurate analytical methods is essential for routine quality monitoring and the detection of counterfeit antibiotics in commercial pharmacies. This paper describes the development and validation of a rapid Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) method for the quantitative determination of ciprofloxacin in tablet dosage forms. Separation was achieved using a C18 stationary phase column under an isocratic mobile phase composed of water-acetonitrile-triethylamine (75:25:0.1 v/v/v), adjusted to pH 3.0 using orthophosphoric acid, at a flow rate of 1.0 mL/min. Eluent monitoring was executed spectrophotometrically at a wavelength maximum of 278 nm. Method validation parameters followed the International Council for Harmonisation (ICH) guidelines. Excellent linearity was established over a concentration range of 1.0 to 50.0 mg/L with a correlation coefficient (R²) of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.05 mg/L and 0.15 mg/L, respectively. Precision assessments yielded relative standard deviations (RSD) below 1.5%. The validated method was successfully applied to screen six commercial ciprofloxacin tablet brands, producing recovery percentages between 98.4% and 101.2% with no interference from common tablet excipients.

Keywords: RP-HPLC; Ciprofloxacin; Quantitative analysis; Method validation; Pharmaceuticals; Quality control

Manuscript Timeline: Received: May 02, 2013; Revised: June 15, 2013; Accepted: July 20, 2013; Published: May 09, 2014.

Citation: Effiong, E. O., & Silva., A. G. (2014). Development and Validation of an RP-HPLC Method for Quantitative Monitoring of Ciprofloxacin Formulations. International Journal of Chemistry, 5(5), 33–40.

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