Development and Validation of a Spectrophotometric Method for Quantitative Determination of Norfloxacin in Pharmaceutical Tablets

International Journal of Chemistry | Vol. 7, No. 1, January 2016 | pp. 1–8

DOI: 10.46882/2016/IJC/000088

Article Type: Original Research Paper

Title: Development and Validation of a Spectrophotometric Method for Quantitative Determination of Norfloxacin in Pharmaceutical Tablets

Names of Authors: E. O. Effiong¹, J. M. S. Cardoso²*

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

Abstract: Developing rapid, low-cost analytical protocols is essential for routine quality monitoring and the detection of substandard antibiotic formulations in clinical testing laboratories. This paper describes the development and validation of a simple UV-Vis spectrophotometric method for the quantification of norfloxacin in tablet dosage forms. The analytical procedure relied on the reaction of norfloxacin with 2,4-dinitrophenylhydrazine in an acidic medium, generating a highly stable yellow-colored hydrazone derivative monitored spectrophotometrically at its absorption maximum of 420 nm. Method validation parameters followed the International Council for Harmonisation (ICH) guidelines. Excellent linearity was established over a concentration range of 2.0 to 25.0 mg/L with a correlation coefficient (R²) of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.08 mg/L and 0.24 mg/L, respectively. Precision assessments yielded relative standard deviations (RSD) below 1.8%. The validated method was successfully applied to screen five commercial brands of norfloxacin tablets, producing recovery percentages between 98.6% and 101.4% with no interference from common tablet excipients, making it suitable for routine quality control setups.

Keywords: UV-Vis spectrophotometry; Norfloxacin; Chemical derivation; Method validation; Pharmaceuticals; Quality control

Manuscript Timeline: Received: May 02, 2015; Revised: June 15, 2015; Accepted: July 20, 2015; Published: January 03, 2016.

Citation: Effiong, E. O., & Cardoso, J. M. S. (2016). Development and Validation of a Spectrophotometric Method for Quantitative Determination of Norfloxacin in Pharmaceutical Tablets. International Journal of Chemistry, 7(1), 1–8.

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