Abstract
Author(s): Sadhana Rajput, Charu Pandya, Prakruti Chaudhari
The present work includes a simple, rapid, accurate and precise isocratic RP-HPLC method for estimation of besifloxacin hydrochloride in bulk and its formulation. The simple, isocratic RP-HPLC method involves separation of besifloxacin hydrochloride on reverse phase C8 oyster column (250 mm x 4.6 mm, 5 µm ) with a mobile phase of phosphate buffer (pH 3) :methanol: acetonitrile (50:25:25 % v/v/v). The developed methods were validated successfully according to ICH Q2 (R1) guidelines. The method showed a good linear response with r2 values of 0.999 . The percentage relative standard deviation for the method was found to be less than two, indicating the method is precise. The mean percentage recovery for RP-HPLC method was between 98.34%-101.56% .Besifloxacin hydrochloride in its opthalamic formulation could be accurately determined with assay value of 98.97%. The developed method is specific, selective and robust. The method could be successfully applied for analysis of opthalamic formulation of besifloxacin hydrochloride.
