METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN TABLET DOSAGE FORM BY RP-HPLC
Journal Title: International Journal of Pharmaceutical and Biological Research - Year 2010, Vol 1, Issue 2
Abstract
A simple reverse phase liquid chromatographic method has been developed and subsequently validated for simultaneous determination of Ofloxacin and Ornidazole in combination. The separation was carried out using a mobile phase consisting of 2mM phosphate buffer and Acetonitrile with pH 3.5 adjusted with ortho phosphoric acid in the ratio of 70: 30%v/v. The column used was Phenomenex C18, (250 mm x 4.6 mm i.d, 5m) with flow rate of 1 ml / min using PDA detection at 293 nm. The described method was linear over a concentration range of 5-50 g/ml and 12.5-125 g/ml for the assay of Ofloxacin and Ornidazole respectively. Gatifloxacin (50 g/ml) was used as internal standard. The retention times of Ofloxacin, Ornidazole and Gatifloxacin were found to be 2.1, 2.5 and 5.5min respectively. Results of analysis were validated statistically and by recovery studies. The limit of detection (LOD) and the limit of quantification (LOQ) for Ofloxacin and Ornidazole were found to be 5 and10 μg/ml 10 and 25 μg/ml respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Ofloxacin and Ornidazole bulk drug and in its pharmaceutical dosage form.
Authors and Affiliations
B. Dhandapani* , N. Thirumoorthy , Shaik Harun Rasheed, M. Rama kotaiah , N. Anjaneyalu4
Keywords
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