Development and validation of an rp-hplc method for simultaneous analysis of ofloxacin and ornidazole in tablets

Abstract EN

A simple, sensitive, and inexpensive high performance liquid chromatographic method has been developed for simultaneous determination of ofloxacin and ornidazole in pharmaceutical formulations.

Chromatographic separation was achieved on a BDS-C18-Hypersil column (250 mm x 4.6 mm i.d., 10 μm).

Mobile phase was 80% water (containing 0.55 ml/L of triethylamine as peak modifier) and 20% acetonitrile; final pH was adjusted to 3.0 with orthophosphoric acid.

Detection was done at 284 nm.

Response was a linear function of concentration in the range 1–20 μg/ml for ofloxacin and 2.5-50 μg/ml for ornidazole; the correlation coefficients were 0.9998 and 0.9995, respectively.

The limit of detection were 0.01 and 0.02 μg/ml for ofloxacin and ornidazole respectively, where as limit of quantitation were 0.05 and 0.1 μg/ml .

The accuracy result for ofloxacin and ornidazole at eighty percent drug (80%), hundred percent (100%), and one hundred and twenty percent (120%) were ranged from 99.6-100.9%.

The inter- and intra-day precision was less than 1%.

Total elution time for the two components was less than 9 min.

Keywords: RP-HPLC, Ofloxacin, Ornidazole, Validation.