Abstract
The objective of this work was to develop a simple, sensitive, accurate, precise and reproducible high performance liquid chromatography (HPLC) method for the determination of norfloxacin in pharmaceutical dosage forms. Shimadzo Prominance model L20 AD HPLC system equipped with SPD 20A UV-Vis detector was used for the analysis. The separation was done on RESTEX allure C18 column (3 μm, 15 cm × 4.6 mm), for an isocratic elution a mixture of methanol and water (60:40, v/v) mobile phase at a wavelength of 254 nm. The flow rate was 1.0 mL/min. The RP-HPLC method developed for analysis of norfloxacin was validated with respect to specificity, selectivity, linearity, accuracy, precision and robustness as per the ICH guidelines. The retention time of norfloxacin was 7.5 min. The linearity was established over the concentration ranges of 50-350 μg/mL with correlation coefficients ( r2) 0.999. The percentage accuracy of norfloxacin ranged from 99.76 -101.66%. The relative standard deviation values for intra-day and inter-day precision was lower than 2.0% and the assay result was found to be 100.65 %. Norfloxacin was subjected to stress conditions such as neutral, acidic, alkaline, oxidation and photolysis degradations as per ICH guidelines. The degradation studies revealed that the drug was found to degrade maximum (1.67%) in alkaline degradation conditions and was highly resistant towards neutral, acidic, oxidative and photolytic degradation conditions.
 Keywords: Norfloxacin, Validation, Stability-indicating, stress degradation, ICH guidelines.
Highlights
Norfloxacin chemically known as 1-ethyl-6fluoro-4-oxo-7-piperazin-1-yl-1H-quinoline-3carboxylic acid is a broad spectrum synthetic fluoroquinolone antibiotic (Fig. 1)
The high performance liquid chromatography (HPLC) method carried out in the present experimental work was aimed at developing a new system capable of eluting resolving norfloxacin and its degradations products
The proposed method for the determination of norfloxacin based on the RP-HPLC method with spectrophotometric detection was shown to be reliable, simple, accurate, sensitive and precise
Summary
Norfloxacin chemically known as 1-ethyl-6fluoro-4-oxo-7-piperazin-1-yl-1H-quinoline-3carboxylic acid is a broad spectrum synthetic fluoroquinolone antibiotic (Fig. 1). Norfloxacin is the first synthetic second-generation fluoroquinolone antimicrobial drug. It was developed for use in human and veterinary medicine [1]. Norfloxacin, occasionally used to treat common, as well complicated urinary tract infections, exhibits a broad spectrum of activity against Gram-positive and Gram-negative bacteria [2,3,4]. It is 1-ethyl-6fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinoline carboxylic acid (Figure 1). The mechanism of the bacterial effect of Journal of Biomedical and Pharmaceutical Research norfloxacin is based on the primary target in bacterial enzyme
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