A NOVEL RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF BALOFLOXACIN IN TABLETS
Objective: To develop a rapid, accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Balofloxacin in tablets.
Methods: The optimized method uses a reverse phase column, Enable Make C18G (250 X 4.6 mm; 5Î¼), a mobile phase of triethylammonium phosphate buffer (pH 2.3): acetonitrile in the proportion of 20:80 v/v, flow rate of 1.0 ml/min and a detection wavelength of 280 nm using a UV detector.
Results: The developed method resulted in Balofloxacin eluting at 2.6 min. Balofloxacin exhibited linearity in the range 2.5-7.5Î¼g/ml. The precision is exemplified by relative standard deviation of 1.08%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies.
Conclusion: A rapid, accurate, precise and linear isocratic RP-HPLC method was developed and validated for the quantitative estimation of Balofloxacin in tablets as per ICH guidelines and hence it can be used for routine analysis in various pharmaceutical industries.
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