The article describes a simple, sensitive, rapid, accurate, precise and specific RP-HPLC method for the simultaneous estimation of ofloxacin and ornidazole with their related impurities in the i.v. infusion dosage form. The chromatography is carried out using merck purospher STAR RP C18® (250 mm x 4.6 mm, 5 µm particle size) column and mixture of phosphate buffer and acetonitrile in the ratio (85:15 v/v) at flow rate of 0.9 ml/min as mobile phase. Detection was carried out at 300 nm using PDA detector. The retention time of ofloxacin and ornidazole were found to be 8.72 min and 14.67 min respectively while for ofloxacin related compound A and 2- methyl-5- nitro imidazole, retention time were 8.20 min and 4.80 min respectively. The LOD value for ofloxacin, ornidazole, ofloxacin related compound A and 2- methyl-5-nitro imidazole were found to be 0.26 µg/ml, 0.41 µg/ml, 0.055 µg/m and 0.05 µg/ml respectively. The LOQ value for ofloxacin, ornidazole, ofloxacin related compound A and 2-methyl-5-nitro imidazole were found to be 0.79 µg/ml, 1.41 µg/ml, 0.18 µg/ml and 0.18 µg/ml respectively. The developed method can be applied effectively and successfully for determination of ofloxacin, ornidazole, ofloxacin related compound A and 2- methyl-5-nitro imidazole in the intravenous infusion dosage form.
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