Stability Indicating Methods for the Determination of Norfloxacin in Mixture with Tinidazole

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Three stability indicating assay methods are developed for the determination of norfloxacin (Nor) in the presence of its decarboxylated degradation product and in mixture with tinidazole (Tnd). The proposed methods are reversed phase ion pair liquid chromatography (LC), thin layer densitometry (TLC) and second derivative ratio spectra zero crossing spectrophotometry (^2DD). Chromatographic separation was achieved on μ-Bondapack C18 column 5μm (300mm×3.9mm, I.D.) and precoated silica gel TLC stationary phases for LC and TLC methods, respectively. Mobile phases consisting of phosphate buffer pH 3.2: methanol (3:1, v/v) containing 0.005M pentane sulfonic acid sodium salt and isopropanol: butanol: concentrated ammonia: water (25:50:5:25, v/v/v/v) were used for resolution of Nor and Tnd by both techniques, respectively. Detection was carried at 280nm. In the ratio spectra method, detection of Nor was carried at 282nm. Linearity, accuracy and precision were found to be acceptable over concentration ranges of 20-225μg/ml, 0.8-4μg/spot and 1-7μg/ml for Nor by LC, TLC and ^2DD methods and over concentration ranges of 37.5-375μg/ml and 4.8-20μg/spot for Tnd by LC and TLC methods respectively. The suggested methods were successfully applied for the determination of both drugs in bulk powder, laboratory prepared mixtures and in commercial samples. Statistical comparison between the results obtained by the proposed and the reference methods was carried out using Student t-test, F ratio and one way ANOVA.
公益社団法人日本薬学会の論文
2007-01-01

Stability Indicating Methods for the Determination of Norfloxacin in Mixture with Tinidazole

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