DISCRIMINATORY DISSOLUTION METHOD DEVELOPMENT AND VALIDATION FOR CEPHALEXIN OD TABLETS

In this study, a discriminative dissolution method was developed for Cephalexin OD (orally disintegrating) tablets 750mg. The solubility and stability of the cephalexin API was determined in ten different solutions. In that 0.01N HCl, glycine buffer pH 3-0, acetate buffer pH 4.5 and water gave good stability and the solubility. Dissolution profiling of cephalexin OD tablets 750mg 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 0.01N HCl with 0.75% of tween 80, 0.01N HCl with 0.5% of SLS, acetate buffer with 1% of tween 80 and water with 0.5% of SLS. With the selected media, dissolution profile was done on the three different batches of cephalexin OD tablets one with lesser polymer ratio and other with higher polymer ratio that that of the test batch. Only 0.01N 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 the parameters