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Stability of an Oral Liquid Dosage Form of Trovafloxacin Mesylate and Its Quantitation in Tablets Using High-Performance Liquid Chromatography

Author(s):  Gupta Vishnu D

Issue:  May/Jun 2000 - Compounding for the Ear, Nose and Throat
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Abstract:  A high-performance liquid chromatographic assay method for the quantitation of trovafloxacin in film-coated tablets and an oral liquid dosage form (10 mg/mL) prepared from tablets has been developed. The assay method is very simple, precise and accurate, with a percent relative standard deviation of 1.8 based on five injections. The recovery from the tablets and the oral liquid dosage form was very close to the label claims. The method is stability indicating, since the peak from a degraded sample (using sodium hydroxide) did not interfere with the assay procedure. Furthermore, a number of excipients present in the tablets and the oral liquid dosage form did not interfere with the developed method. The oral liquid dosage form gave uniform results and the drug was stable for at least 14 days when stored in an amber-colored glass bottle at 25°C (± 1). The pH of the formulation did not change.

Related Keywords: acetonitrile, antibiotic, assay, degraded, fluoronaphthyridone, high-performance, liquid chromatography, liquid dosage form, method, oral liquid, stability, stable, tablets, trovafloxacin


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