STABILITY INDICATING RP-HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF BALOFLOXACIN IN TABLETS

The article aims at developing a rapid, sensitive, accurate, precise and linear stability indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) assay method and validate as per ICH guidelines for the estimation of Balofloxacin in tablets. The optimized method employs a reverse phase column, Phenomenex Kinetex C18 (250X4.6mm;5μ), a mobile phase of Potassium dihydrogen phosphate buffer (pH 2.5):acetonitrile in the proportion of 50:50 v/v, flow rate of 0.6ml/min and a detection wavelength of 220 nm using a UV detector. Optimized method separated all the forced degradant impurities from the drug peak. Linearity of the method was 15-45μg/ml. Intra day and Inter day precision were exemplified by relative standard deviation of 1.09 and 1.17% respectively. Percentage mean recovery was found to be in the range of 90‐110, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 247.9ng/ml and 751.2ng/ml respectively. Keywords: Balofloxacin, stability indicating HPLC, validation.