Analytical method validation on simultaneous estimation of Ozenoxacin and Benzoic acid in pharmaceutical formulation

Abstract In this study, an accurate, simple, economical and precise Reversed-Phase High Pressure Liquid Chromatography (RP-HPLC) method was developed for the simultaneous estimation of Ozenoxacin Benzoic Acid in a pharmaceutical cream formulation, according to International Conference on Harmonisation (ICH) guidelines. Chromatographic separation achieved by gradient elution, RP-HPLC Instrument, equipped with column C8 (150 mm × 4.6 mm, 5 μm particle size) using Ultra Violet (UV) detector at 235 nm wavelength, Mobile Phase A: triethylamine, trifloroacetic acid water (1:1:1000) B: methanol Diluent: water, acetonitrile triethylamine (500:500:1), flow rate 0.8 mL min −1 ; injection volume 20 μL; oven temperature 45 °C sample temperature: 25 °C; Run time: 15 min. All validation parameters were within acceptance criteria, as per ICH requirements, acid. Consequently, has found be validated, rapid successfully applicable, RP-HPLC, routine analytical testing quality control, run time future research studies. Forced degradation 1% w/w formulation performed that validated stability indicating potential needs further studied.