Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF BALOFLOXACIN AND ORNIDAZOLE IN THEIR COMBINED DOSAGE FORM

Majithia Shivani*, Kalthiya Tushalkumar, Patel Naitik, Zarna Dedania, Ronak Dedania

Abstract

A RP-HPLC method is developed for simultaneous estimation of Balofloxacin and Ornidazole in combined tablet dosage form. Balofloxacin comes in the category of antibacterial and antibiotic and it is used in infective ophthalmitis and sinusitis, chronic bronchitis, acute exacerbation, community-acquired pneumonia, skin infections, intra abdominal infection. Ornidazole comes in category of antiprotozoal, antibiotic and anti microbial and it is used in intestinal and hepatic amoebiasis, giardiasis, trichomoniasis, bacterial vaginosis, anaerobic infections. The mobile phase used was a combination of the mobile phase composed of phosphate buffer: acetonitrile (70:30%, v/v), pH-3.1 adjusted with trimethylamine. The eluent detection was carried out by using photodiode array detector at 308 nm and flow rate at 1.0 ml/min. The linearity range for Balofloxacin and Ornidazole was found to be in the range of 2.5- 7.5μg/ mL, and 12.5-37.5μg /mL respectively. Correlation co-efficient of Balofloxacin and Ornidazole was found to be 0.9903 and 0.9971 respectively. The method used was Cosmosil packed MS II column C18 at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. The methods were found to be simple, accurate, economical, robust and reproducible, which can be employed for routine analysis of the drugs in combined dosage form.

Keywords: Balofloxacin, Ornidazole, RP-HPLC method, simultaneous estimation.