Development and Validation of a Simple, Rapid and Stability-Indicating High Performance Liquid Chromatography Method for Quantification of Norfloxacin in a Pharmaceutical Product

Abstract

A stability-indication high performance liquid chromatographic method has been developed for the determination of norfloxacin in tablet dosage forms. Optimum separation was achieved in less than 7 minutes using Eclipse Plus Zorbax C18 Agilent, 150 mm×4.6 mm i.d., 5 μm particle size column. The analyte was resolved by using a mobile phase 5% acetic acid aqueous solution and methanol (80:20, v/v) at a flow rate 1.0 ml/min on an isocratic high performance liquid chromatographic system at a wavelength of 277 nm. Linearity, system suitability, precision, sensitivity, selectivity, specific, and robustness were established by International Conference Harmonization guidelines. For stress studies the drug was subjected to photolysis, oxidation, acid, alkaline and neutral conditions. The analytical conditions and the solvent developed provided good resolution within a short analysis time and economic advantages. The proposed method not required sophisticated and expensive instrumentation.

Besifloxacin: A Critical Review of Its Characteristics, Properties, and Analytical Methods

“…Not informed [46] HPLC [47] (continued on next page) other fluoroquinolones, such as orbifloxacin, [53] norfloxacin, [54] and sparfloxacin. [55,56] Ultra-efficient liquid chromatography (U-HPLC), in turn, was used to analyze besifloxacin and other quinolones in cosmetics [57] and in a mixture of R-besifloxacin and S-besifloxacin enantiomers.…”

Development and validation of a method for phenobarbital in serum: anticonvulsant pharmacotherapy monitoring

“…The robustness measures the method's ability to remain selective, accurate and precise front to small changes in the experimental conditions that may occur during routine analysis (Chierentin & Salgado, 2013). One can vary the proportion of the mobile phase, column temperature, wavelength, etc.…”

Spectrophotometric Determination of Norfloxacin in Pharmaceutical Formulations Based on Charge Transfer Reaction with Quinalizarin

“…1b) is tetrahydroxyanthroquinone isomer commonly used as spectrophotometric reagent. Several methods have been reported in the literature for the analysis of norfloxacin such as HPLC 6 , spectrofluorometry 7 , capillary electrophoresis 8 , voltammetry 9 , flow injection technique 10 potentiometric titration 11 , mass spectroscopy 12 , etc.…”