Development and validation of a method for simultaneous estimation of ofloxacin and ornidazole in different dissolution media.

INTRODUCTION: Ofloxacin and ornidazole in a combined tablet dosage form is available in the market. This combination has gained increasing acceptance in diarrhea caused due to bacterial and protozoal infections. Ofloxacin and ornidazole are also combined in the capsule dosage form to modify its release pattern in different studies. Spectrophotometric and HPTLC methods have been reported for their simultaneous estimation in the tablet dosage form in specific solvents. This paper presents a simple, accurate, and reproducible spectrophotometric method for simultaneous estimation of ofloxacin and ornidazole in the tablet dosage form in different dissolution media. The reported method is helpful in determination of ofloxacin and ornidazole during a dissolution study.

MATERIALS AND METHODS: A simple, sensitive, accurate, and economical spectrophotometric method based on the simultaneous equation was developed for the estimation of ornidazole and ofloxacin simultaneously in the tablet or capsule dosage form in different dissolution media at different pH values.

RESULTS: Ofloxacin showed absorption maxima at 294 nm in 0.1 N HCl and at 287 nm in phosphate buffer pH 6.8 and phosphate buffer pH 7.4 while ornidazole showed absorption maxima at 277 nm in 0.1 N HCl and at 319 nm in two buffers, respectively. The linearity was obtained in the concentration range of 1-8 μg/ ml for ofloxacin and 4-26 μg/ml for ornidazole.

DISCUSSION: The concentrations of the drugs were determined by the simultaneous equation method. The results of analysis have been validated statistically and by recovery studies.