Development and Validation of UV-Spectrophotometric Method for Estimation of Sparfloxacin In Gastric Simulatory Media In Bulk and Pharmaceutical Dosage Forms

ABSTRACTThe main objective of this study was to develop and validate an UV-spectrophotometric method for the estimation of sparfloxacin in 0.1 N HCl (gastric simulatory media) as per ICH guidelines. The ?max for sparfloxacin in 0.1 N HCl was found to be 296 nm. The drug follows linearity in-between the concentration range of 2-12?g/ml with a correlation coefficient value of 0.999. The proposed method was applied onto the bulk and marketed pharmaceutical formulation (tablets) so as to find out contents of drug. Estimated drug was found to be in-between 98.43 to 101.57 % in marketed tablets, a good agreement with the claimed level. The accuracy of the method was verified by recovery experiment performed at three different levels- 75%, 100%, and 125%. The % recovery was found to be in the range of 97.31-101.45%. The accuracy and reproducibility of the method was indicated by low values of % RSD. The precision of the method was studied through intraday and Interday variations and repeatability. The % RSD value< 2 confirmed the precision of developed method. Ruggedness of the proposed method was studied with the help of two analysts. The proposed method was found to be a rapid yet successful tool for routine analysis of sparfloxacin in the bulk and in the pharmaceutical dosage forms. Keywords: Fluorquinolone; sparfloxacin, Quantitative determination, UV, validation.