DISSOLUTION METHOD DEVELOPMENT FOR GASTRO RETENTIVE CONTROLLED RELEASE CEPHALAXIN TABLET

Abstract

Cephalexin is in a group of drugs called cephalosporin antibiotics and is used to fight bacteria in the body. It works by interfering with the bacteria's cell wall formation, causing it to rupture, and killing the bacteria. A controlled release tablet dissolution method was developed for evaluation of Cephalaxin CR tablet & determination of Cephalaxin is done by UV spectrophotometer. The solubility and stability of the cephalexin API was determined in ten different solutions. In that 0.1N HCl, glycine buffer pH 3.0, acetate buffer pH 4.5 and water gave good stability and the solubility. Dissolution profiling of cephalexin   gastroretentive controlled release (GR CR of single batch was done with the selected media containing varying concentration of   surfactants (tween 80 and Sodium lauryl sulphate- SLS). The release profile is compared with that of the control media. The media that gave discriminately faster release than that of the control were found to be 0.1N HCl with 0.75% of tween 80, With the selected media, dissolution profile was done on the three different batches of cephalexin GR CR tablets one with lesser polymer ratio and other with higher polymer ratio that that of the test batch. Only 0.1N HCl with 0.75% of tween 80 as dissolution medium was found to show good discrimination in the release profile with change in the formulation conditions. The discriminative dissolution method developed was validated for its specificity, accuracy, stability, linearity and precision and it passes all parameters.