Development of RP-HPLC Method for the Quantitative Estimation of Ofloxacin and Ornidazole in Combined Liquid Oral Dosage Forms

A simple, efficient and reproducible reversed phase high performance liquid chromatographic (RP-HPLC) method for the quantitative estimation of ofloxacin and ornidazole in bulk and in combined liquid oral dosage form has been developed and validated. The separation was carried out using thermohypersil phenyl column (250 mm × 4.6 mm, 5 μm) as stationary phase with isocratic flow and phosphate buffer (adjusted to pH 2.4 with ortho phosphoric acid): acetonitrile (87:13 v/v) as mobile phase. Mobile phase was maintained at a flow rate of 1.0 ml/min and UV detection was carried out at 294 nm. The retention time of ofloxacin and ornidazole was 10.40 and 5.69 min, respectively. All calibration curves showed good linear correlation coefficients within the tested limits (r2 > 0.9995). The linear dynamic range was 10-100 µg/ml and 25-250 µg/ml for ofloxacin and ornidazole respectively. Percentage recoveries for ofloxacin and Ornidazole were 100.48 % and 99.84 % respectively. All the analytical validation parameters were determined and found in the limit as per the International Conference on Harmonization (ICH) guidelines, which indicates the validity of the method. The validated method is also found to be accurate, precise and robust for the quantitative estimation of ofloxacin and ornidazole in combined liquid oral dosage forms.