A novel validated RP-HPLC method for the determination of balofloxacin in bulk and pharmaceutical dosage forms


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Volume :

3

Issue :

2

Abstract :

A simple, specific, accurate, selective isocratic reversed phase-high performance liquid chromatography (RP-HPLC) method was developed for the quantitative estimation of balofloxacin in pharmaceutical formulations. RP-HPLC method was developed by using WELCHROM C18 Column (4.6 X 250mm, 5µm), SHIMADZU LC-20AT prominence liquid chromatograph. The mobile phase composed of phosphate buffer: acetonitrile (70:30%, v/v), pH-3.1 adjusted with triethylamine. The responses are measured at 293nm using SHIMADZU SPD-20A prominence UV-Vis detector. The retention time of balofloxacin was found to be 6.253 min. Linearity was established for balofloxacin in the range of 1-10 µg/ml with correlation coefficient 0.999. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision and specificity according to ICH guidelines. This method can be successfully employed for quantitative analysis of balofloxacin in bulk drugs and formulations.
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