Ornidazole

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Ornidazole in injection formulations. The separation was achieved by using column Inertsil ODS-3V (150×4.6 mm, 5µ), in mobile phase consisted of acetonitrile and pH 3.0 phosphate buffer, adjusted to pH 3.0 with the help of dilute orthophosphoric acid in the ratio of (10:90, v/v). The flow rate was 2.0 mL/min-1 and the separated Ornidazole was detected using UV detector at the wavelength of 300 nm. Column temperature 25°C and sample temperature ambient and injection volume 20µL. The retention time of Ornidazole, was noted to be 12.05 min respectively. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.

A simple, rapid, sensitive reverse-phase high-performance liquid chromatography method was developed and validated for simultaneous estimation of ofloxacin and ornidazole, at single wavelength of 343nm.chromotographic separation was performed on an enable aligent zorabax(thermo) column(250nmx4.6mm ID particle size 5 um) and a  mobile phase consisting of acetonitrile and buffer (600:4300v/v) at a flow rate of 1.0ml/min. the calibration curve was linear(r2≥0.0999) over the concentration range. 400-1200μg/mL of ofloxacin and 1000-3000μg/mL of ornidazole. the limit of detection 0.00246µg/ml  for ofloxacin  0.00508µg/ml for ornidazole and no interference was found by the excipients in the synthetic mixture. The proposed methods were validated for international conference on harmonization guideline for linearity, accuracy, precision, and robustness for estimation of ofloxacin and ornidazole in bulk and synthetic mixture, and The results were found to be satisfactory

A simple reverse phase liquid chromatographic method has been developed and subsequently validated for simultaneous determination of Ofloxacin and Ornidazole in infusion dosage form. The separation was carried out using a mobile phase containing methanol and buffer (equal proportion of 0.01M orthophosphoric acid and 0.01M sodium phosphate monobasic dihydrate) with pH 4.00 adjusted by 20% of triethylamine in the ratio of 60:40 v/v. The column used was HiQ Sil C18 (150 mm x 4.6 mm i.d, 5 µ) with flow rate of 1 mL / min using UV detection at 300 nm. The described method was linear over a concentration range of 1.25-10 µg/mL (r2>0.9991) for Ofloxacin and 3.12-25 µg/mL (r2>0.9992) for Ornidazole. Separation was achieved within 5 min. The mean % recovery was found to be 99.94% for Ofloxacin and 100.27 % for Ornidazole. The limit of detection (LOD) for Ofloxacin and Ornidazole were found to be 0.146 and 0.25 µg/mL respectively. Whereas the limit of quantification (LOQ) for Ofloxacin and Ornidazole was 0.44 and 0.77 µg/mL respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise, accurate and cost effective which is useful for the routine determination of Ofloxacin and Ornidazole in bulk drug and in its infusion.