Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN PRESENCE OF ORNIDAZOLE IMPURITY IN COMBINED PHARMACEUTICAL DOSAGE FORM

Farrel Lisa Gauncar* and Sachi S. Kudchadkar

Abstract

A simple, rapid, accurate and precise RP-HPLC method has been developed for simultaneous estimation of Ofloxacin and Ornidazole and Ornidazole Impurity A in combined dosage form. The column used was Phenomenex C18 (250 mm×4.6 mm, 5μm) with a flow rate of 1.0 ml/min using UV detection at 318 nm. The chromatographic separation was carried out using mobile phase containing ACN: Phosphate buffer at pH 3.0 adjusted with OPA in the ratio of 40:60 v/v. The described method was validated and linearity was observed over a concentration range of 2-20 μg/ml for Ofloxacin, 5-50 μg/ml for Ornidazole and 0.5-2 μg/ml for Impurity A with correlation coefficient of (R2˃0.999). All components were well resolved within 5 minutes. The proposed method can be applied effectively during routine purity testing and successfully for determination of Ofloxacin, Ornidazole and Ornidazole Impurity A in bulk and pharmaceutical dosage form.

Keywords: Ofloxacin, Ornidazole, ORN Impurity A, RP-HPLC, Validated.