HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF DELAFLOXACIN IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Nischhala Kumari, Ravindra Kumar Chourasiya
ABSTRACT
A simple, rapid, and precise reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of Delafloxacin in bulk drug and pharmaceutical tablet dosage forms. Chromatographic separation was achieved on a suitable C18 column using an optimized mobile phase under isocratic conditions, with UV detection at an appropriate wavelength. Delafloxacin showed a well-resolved and symmetrical peak with a retention time of 6.861 min. System suitability parameters confirmed adequate chromatographic performance, with a theoretical plate count of 3200.83 and a tailing factor of 1.1467. The method was linear over the concentration range of 1–5 ?g/mL with a correlation coefficient (r²) of 0.9992. Accuracy studies demonstrated mean recoveries between 99.20% and 99.77%, indicating absence of interference from excipients. Precision studies showed low variability with %RSD values well within acceptable limits for both repeatability and intermediate precision. The method was found to be robust against small deliberate variations in chromatographic conditions. Assay of the marketed tablet formulation revealed a drug content of 99.96% with %RSD of 0.246. The validated RP-HPLC method is accurate, precise, robust, and suitable for routine quality control analysis of Delafloxacin in bulk and pharmaceutical dosage forms.
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