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A VALIDATED STABILITY INDICATING HPLC METHOD FOR PRULIFLOXACIN

Keywords: Spectrophotometry , Prulifloxacin , RP-HPLC.

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Abstract:

A stability indicating reversed-phase high performance liquid chromatographic (RP-HPLC)method was developed for the quantitative determination of prulifloxacin as a bulk drug. The chromatography was performed on a C18 column. Eluents were monitored by UV detection at273 nm using the mobile phase acetonitrile:water:triethylamine (40:60:0.3%, v/v/v), (pH 3.3).The method was statistically validated for linearity, accuracy, precision and specificity. The linearity of prulifloxacin is within the concentration range of 10–100 μg mL-1. The limits of detection and quantitation were 3.9 and 11.84 μg mL-1, respectively. The method was demonstrated to be precise, accurate and specific with no interference from the peaks of the degradation products (oxidative degradation, photodegradation, acid and base degradation). The results indicated that the proposed method could be used in a stability assay.

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